Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Contracture

Dupuytren Contracture

Joint Diseases

Muscular Diseases

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Connective Tissue Diseases

1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual

percutaneous needle fasciotomi is performed at affected cords

xiapex

percutaneous needle fasciotomy

hallgeir bratberg, MD

The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.

Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.

A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.

The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.

The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.

The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.

Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.

Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.

Exclution criteria:

Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA\>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial

Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

Prospektiv Randomisert Sammenlikning Mellom Percutan nålefasciotomi og Xiapex for Dupuytrens Kontraktur

contracture size mesured in degrees in each finger joint

Quick-DASH functional score measured in points.

Contracture size mesured in degrees in each finger joint

Oslo University Hospital

Injection of collagenase obtained from Clostridium Histolyticum in contracture string

Xiapex

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Jeppe Lange, M.D.

Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.

Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial

Clinical improvement is defined as a contracture reduction 50% or more from baseline.

Jeppe Lange, MD

M:D:

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, Local

percutaneous transection or pretendinous palmar dupytren cord

Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord

Injection of collagenase of primary dupytren cord

26 G needle multiple perforation tecqnique with local anesthetic

Needle aponeurotomy

Per-Henrik Randsborg, PhD

Aim:

Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy.

Materials and methods:

30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°.

1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.

Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications.

There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis.

The treatment arm of Xiapex in this study follows the recommendation as by the producer.

The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended.

The two procedures leave little scar tissue lessening the challenges posed by the reoperations.

Recurrence rate of contracture following different treatments of Dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.

Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.

def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ

University Hospital, Akershus

surgery

Veronica Urdaneta

An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

phase 4, open label, multi-center, prospective non-interventional descriptive

Post Approval Commitment Study

A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture

Endo Pharmaceuticals

Symptoms and General Pathology

Recurrence

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord

Collagenase clostridium histolyticum

Veronica Urdaneta, MD, MPPH

The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Retreatment of Recurrent Dupuytren's Contractures

Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe

Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500

Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees

Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees

Physician global assessment of change (improvement) in subject's Dupuytren's contracture

Subject global assessment of overall treatment satisfaction

Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.

XIAFLEX/XIAPEX: up to three 0.58 mg injections

XIAFLEX/XIAPEX

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Australia

United Kingdom

Sweden

Region of Enrollment

Clinical Trial Coordinator

XIAFLEX/XIAPEX MP Joint

XIAFLEX/XIAPEX PIP Joint

Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure

Clinical Success

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord

Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord

Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure

Percent Change From Baseline in Degree of Contracture

Change in Range of Motion

Very much improved

Much improved

Minimally improved

No change

Minimally worse

Much worse

Very much worse

Not done

Physician Global Assessment of Improvement

Very satisfied

Quite satisfied

Neither satisfied nor dissatisfied

Quite dissatisfied

Very dissatisfied

Subject Global Assessment of Satisfaction

Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed

Recurrence of Contracture

Overall Study

Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol

Pfizer CT.gov Call Center

This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)

Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)

Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.

Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity \[pH\], glucose, protein, blood, ketones, microscopy\[if urine tested positive for blood or protein\]).

Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.

Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.

Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician's rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.

Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.

Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.

Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).

Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.

URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to \>=5 items, then average score of answered questions was imputed response to missing questions.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.

Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.

Results were not reported for fifth injection as no finger received 5 injections.Results are reported for 'number of days of concomitant pain medication' as 'amount of pain medication' was interpreted as total number of days with pain medication use.

Pfizer ClinicalTrials.gov Call Center

Full analysis set(FAS):participants who received at least (\>=)1 injection of Xiapex,had \>=1 post-injection efficacy assessment(goniometric/participant-reported). 'N'(number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

Total Passive Extension Deficit (TPED) at Baseline for First Injection

Baseline for first injection: MP Joint (n=211)

Day 1 after first injection: MP Joint (n=207)

Day 7 after first injection: MP Joint (n=209)

Day 30 after first injection: MP Joint (n=209)

Baseline for second injection: MP Joint (n=33)

Day 1 after second injection: MP Joint (n=33)

Day 7 after second injection: MP Joint (n=33)

Day 30 after second injection: MP Joint (n=32)

Baseline for third injection: MP Joint (n=9)

Day 1 after third injection: MP Joint (n=9)

Day 7 after third injection: MP Joint (n=9)

Day 30 after third injection: MP Joint (n=9)

Baseline for follow-up: MP Joint (n=201)

Follow-up Day 90: MP Joint (n=201)

Follow-up Day 180: MP Joint (n=207)

Baseline for first injection: PIP Joint (n=98)

Day 1 after first injection: PIP Joint (n=98)

Day 7 after first injection: PIP Joint (n=97)

Day 30 after first injection: PIP Joint (n=98)

Baseline for second injection: PIP Joint (n=18)

Day 1 after second injection: PIP Joint (n=15)

Day 7 after second injection: PIP Joint (n=18)

Day 30 after second injection: PIP Joint (n=18)

Baseline for third injection: PIP Joint (n=6)

Day 1 after third injection: PIP Joint (n=6)

Day 7 after third injection: PIP Joint (n=6)

Day 30 after third injection: PIP Joint (n=6)

Baseline for follow-up: PIP Joint (n=93)

Follow-up Day 90: PIP Joint (n=93)

Follow-up Day 180: PIP Joint (n=93)

FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.

Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints

Change at Day 1 after first injection (n=256)

Change at Day 7 after first injection (n=256)

Change at Day 30 after first injection (n=257)

Change at Day 1 after second injection (n=64)

FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.

Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture	NCT02476461	Dupuytrens Cont...	xiapex percutaneous ne...	18 Years -	Oslo University Hospital
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture	NCT01538017	Dupuytrens Cont...	Xiapex Percutaneous ne...	18 Years - 99 Years	Regionshospitalet Silkeborg
Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF	NCT02647619	Dupuytren Contr...	Xiapex Needle aponeuro...	18 Years -	University Hospital, Akershus
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture	NCT01538017	Dupuytrens Cont...	Xiapex Percutaneous ne...	18 Years - 99 Years	Regionshospitalet Silkeborg
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture	NCT02476461	Dupuytrens Cont...	xiapex percutaneous ne...	18 Years -	Oslo University Hospital
Post Approval Commitment Study	NCT01444729	Dupuytren's Con...	Xiapex surgery	18 Years -	Endo Pharmaceuticals
Retreatment of Recurrent Dupuytren's Contractures	NCT01498640	Dupuytren's Dis...	Collagenase clo...	18 Years -	Endo Pharmaceuticals
Post Approval Commitment Study	NCT01444729	Dupuytren's Con...	Xiapex surgery	18 Years -	Endo Pharmaceuticals
Post Approval Commitment Study	NCT01444729	Dupuytren's Con...	Xiapex surgery	18 Years -	Endo Pharmaceuticals
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)	NCT01229436	Dupuytren's Con...	Xiapex	18 Years - 70 Years	Pfizer
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)	NCT01229436	Dupuytren's Con...	Xiapex	18 Years - 70 Years	Pfizer
Retreatment of Recurrent Dupuytren's Contractures	NCT01498640	Dupuytren's Dis...	Collagenase clo...	18 Years -	Endo Pharmaceuticals
Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease	NCT03331926	Dupuytren Contr...	Xiapex	18 Years -	Horsens Hospital

Spots Global Cancer Trial Database for xiapex

Every month we try and update this database with for xiapex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xiapex

Every month we try and update this database with for xiapex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xiapex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.