Musculoskeletal Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Immune System Diseases

Arthritis

Necrosis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Anesthetics

Antibodies

Immunoglobulins

Certolizumab Pegol

Immunoglobulin Fab Fragments

Tumor Necrosis Factor Inhibitors

Immunosuppressive Agents

Immunologic Factors

Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks with arthroscopic synovial tissue biopsy pre- and post-treatment.

CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.

Certolizumab Pegol (CZP)

Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.

Arthroscopic synovial tissue biopsy

Nathan Wei, MD,FACP,FACR

The purpose of this study is to conduct an Investigator-Sponsored Study to determine the potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.

Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression

Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.

The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.

University of California, San Diego

Nathan Wei, MD, FACP, FACR:

Nathan Wei, MD, FACP, FACR

Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.

Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.

Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.

>18 years of age

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

All subjects who meet screening criteria were enrolled until target number of 12 subjects was met.

Nathan Wei, MD

TNFa

CXCL13

IL-8

IL-6

IL-1b

IL-10

IP-10

BCL3

CD3E

DUSP4

FOXP3

CD79A

CD138

MMP-3

MMP-1

Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis

Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment

Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.

Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.

Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.

Overall Study

All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC

UCB Clinical Trial Call center

This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.

The purpose of this study is to assess the clinical efficacy of Cimzia in achieving clinical remission after two years of therapy. The observational nature of the study leaves the therapeutic decision exclusively within the discretion of the treating physician.

Observation of Treatment With Certolizumab Pegol in Daily Practice

A Multicenter, Observational, Non-interventional Study to Evaluate the Safety and Efficacy of Anti-TNF (Anti-Tumor Necrosis Factor) Alpha Therapy With Certolizumab Pegol Observed in Daily Practice in Adult Rheumatoid Arthritis (RA) Patients

The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.

For the analysis, DAS28 values were categorized into the following groups:

* DAS28 \< 2.6: clinical remission
* DAS28 from 2.6 to ≤ 3.2: low disease activity
* DAS28 from \> 3.2 to 5.1: moderate disease activity
* DAS28 \> 5.1: high disease activity

Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).

The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).

The CDAI was calculated with the equation:

CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).

UCB Pharma GmbH

Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.

Cimzia

<=18 years

Between 18 and 65 years

>=65 years

Missing

One subject's age data was missing. Age continuous calculation is based on n=1116.

Age, Continuous

Baseline Characteristics refer to the Enrolled Set.

UCB (Study Director)

Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.

Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6

Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.

Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)

Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)

Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)

Digestive System Diseases

Rare Diseases

Crohn Disease

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Gastrointestinal Diseases

Chronic Graft Versus Host Disease

400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks

400 mg subcutaneous (sc) injection of Certolizumab pegol (CDP870) every 2 (Q2W) or 4 (Q4W) weeks

Certolizumab pegol (CDP870)

UCB Clinical Trial Call Center

The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 \[NCT00308581\]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.

Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.

Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection.

Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response \[CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)\] at 2 consecutive visits.

A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects maintaining response at Last visit.

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI).

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects achieving clinical response at Last visit.

Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Results are presented as the percentage of subjects in remission at Last visit.

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI)

Loss of response = both a CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Follow-up period starts the day after the last injection up to 84 days after last injection.

Overall period corresponds to both treatment and follow-up periods in C87046.

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the treatment period.

Follow-up period starts the day after the last injection up to 84 days after last injection.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.

Follow-up period start the day after the last injection up to 84 days after last injection.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.

Overall period corresponds to both treatment and follow-up periods in C87046.

Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics.

Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.

Follow-up period start the day after the last injection up to 84 days after last injection.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.

Overall period corresponds to both treatment and follow-up periods in C87046.

Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.

UCB Pharma

Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.

Certolizumab Pegol 400 mg

Baseline characteristics are based on the ITT population; Participant flow is based on the All Subjects population.

Age, Categorical

France

Canada

Spain

Belgium

Austria

Netherlands

Germany

United Kingdom

Switzerland

Italy

Sweden

Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)

Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).

Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)	NCT01374971	Rheumatoid Arth...	Certolizumab Pe... Arthroscopic sy...	18 Years -	Arthritis Treatment Center, Maryland
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)	NCT01374971	Rheumatoid Arth...	Certolizumab Pe... Arthroscopic sy...	18 Years -	Arthritis Treatment Center, Maryland
Observation of Treatment With Certolizumab Pegol in Daily Practice	NCT01069419	Rheumatoid Arth...		18 Years -	UCB Pharma
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease	NCT00333788	Crohn's Disease	Certolizumab pe...	18 Years -	UCB Pharma

Spots Global Cancer Trial Database for cimzia

Every month we try and update this database with for cimzia 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 cimzia

Every month we try and update this database with for cimzia 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 cimzia 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.