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

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Analgesics

Gastrointestinal Agents

Antiemetics

Neuroprotective Agents

Dermatologic Agents

Rituximab

Prednisolone

Abatacept

Etanercept

Adalimumab

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Infliximab

Certolizumab Pegol

Golimumab

Antineoplastic Agents, Immunological

Immunologic Factors

Tumor Necrosis Factor Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Immunosuppressive Agents

Immune Checkpoint Inhibitors

Etanercept will be administered at a dose of 50mg by subcutaneous injection per week for a total of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.

The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique.

Abatacept will be administered at a dose determined by body weight:

Body Weight (kg) Dose (mg) \< 60kg = 500 mg

\> or equal to 60kg and \< or equal to 100kg = 750 mg \> 100 kg = 1000mg

The intravenous infusions will be administered in clinic on days 1, 15, 29 and every 28 days thereafter for a minimum of 24 weeks. Further treatment will be prescribed at the discretion of the treating clinician.

Rituximab will be given at a dose of 1000mg; 2 intravenous infusions will be administered at days 0 (week 0) and 15 (week 2).

In line with standard practice, a patient who loses an initial response with a DAS28 increase of at least 0.6 may receive a further cycle of rituximab at the discretion of the treating clinician.

Prior to receiving rituximab, intravenous methylprednisolone 100mg will also be given.

Adalimumab will be given at a dose of 40mg by subcutaneous injection every two weeks for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.

The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique.

Certolizumab Pegol will be given at a dose of 400mg by subcutaneous injection at weeks 0, 2, 4and then at a dose of 200mg every two weeks thereafter for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.

The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique.

Infliximab will be given at a dose of 3mg/kg per intravenous infusion in clinic.

The intravenous infusions will be administered at week 0, 2, 6 and then 8-weekly thereafter for a minimum of 12 weeks.

Further treatment will be prescribed at the discretion of the treating clinician.

Golimumab will be given at a dose of 50mg by subcutaneous injection every 4 weeks for a minimum of 24 weeks.

Further treatment will be prescribed in line with the study protocol and following week 48, at the discretion of the treating clinician.

The participant will be taught how to administer the subcutaneous injection and injections will be monitored according to local arrangements until the participant is proficient with the technique according to local practice.

Maya Buch

The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug

Change in Disease Activity Score 28 (DAS28) at 6 months (24 weeks).

Proportion of participants who achieve a reduction in DAS28 score of greater than 1.2 from baseline at weeks 12, 24, 36 and 48 with no toxicity.

EULAR Response Scores and American College of Rheumatology (ACR) Response Scores (evaluated at weeks 12, 24, 36, 48).

Change in CDAI score from baseline at weeks 12, 24, 36 and 48. Proportion of participants in each CDAI category at weeks 12, 24, 36 \& 48.

Change in SDAI score from baseline at weeks 12, 24, 36 \& 48. Proportion of participants in each SDAI category at weeks 12, 24, 36 \& 48.

Proportion of participants that achieve Boolean remission rate at weeks 12, 24, 36 \& 48.

RA Quality of Life (RAQoL) score Health Assessment Questionnaire Disability Index (HAQ-DI) (also evaluated at weeks 60, 72, 84 \& 96) Hospital Anxiety and Depression Scale (HADS)

EuroQol 5-dimensions (EQ-5D) (also evaluated at weeks 60, 72, 84 \& 96) Health Utilities Index (also evaluated at weeks 60, 72, 84 \& 96) Health and Social Care Use \& Expenditure due to Rheumatoid Arthritis (evaluated at weeks 12, 24, 36 \& 48) Incremental Cost Effectiveness

Change in plain x-ray score of hands and feet (Modified Genant score - evaluated at baseline and week 48) Bone densitometry scan scores (T-scores unilateral neck of femur and lumbar spine - evaluated at baseline and week 48)

Julia Brown

Director of Leeds Institute of Clinical Trials Research

Central Nervous System Depressants

Anesthetics

Antibodies

Immunoglobulins

Immunoglobulin Fab Fragments

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

Digestive System Diseases

Crohn Disease

Fistula

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Certolizumab pegol

Krassimir Mitchev, MD

To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.

UCB Pharma

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.

UCB Clinical Trial Call Center

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Mucosal Healing Study in Crohn's Disease (CD)

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease.

Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline). 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.

Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.

The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes. Scores range from 0 to 44, with higher scores indicating greater disease

Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.

CDP870 400 mg

Note: The 4 patients in the '\<=18 years' category were all 18 years of age at Baseline.

Age, Categorical

Age Continuous

France

Belgium

Germany

Of the 89 patients in the Intent to Treat Population, 78 patients had data at both Baseline and Week 10, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 51 patients were in the subpopulation who had a blinded assessment at Week 10 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 10 by the total number of patients with data collected, multiplied by 100.

Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 33 patients were in the subpopulation who had a blinded assessment at Week 54 and are included here. Percentage of patients is calculated by dividing the number of patients who achieved mucosal healing at Week 54 by the total number of patients with data collected, multiplied by 100.

Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at both Baseline and Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and at Baseline, and are included here. Percentage patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 10 by the number of patients with CDEIS data at Baseline and Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54 and at Baseline, and are included here. Percentage of patients is calculated by dividing the number of patients with a CDEIS decrease of at least 5 points at Week 54 by the number of patients with CDEIS data at both Baseline and Week 54, multiplied by 100.

Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments

Of 89 patients in the Intent to Treat Population 28 had matching nonblinded/blinded assessments and are in the subpopulation with blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number patients with CDEIS decrease of at least 5 points at Week 54 by the number with CDEIS at Baseline and Week 54, multiplied by 100

Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 44 patients were in the subpopulation with a blinded assessment at Week 10 and Baseline, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments

Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<6 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 78 patients had data at Week 10, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments

Of the 89 patients in the Intent to Treat Population, 44 patients had a blinded assessment at Week 10 and Baseline, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 10 by the total number of patients with CDEIS data at Week 10, multiplied by 100.

Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 53 patients had data at Week 54, and are included in this summary. Percentage of patients is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments

Of 89 patients in the Intent to Treat Population, 28 had matching nonblinded/blinded assessments and were in the subpopulation with a blinded assessment at Week 54 and Baseline. Percentage is calculated by dividing the number of patients with a CDEIS score \<3 at Week 54 by the total number of patients with CDEIS data at Week 54, multiplied by 100.

Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments

Of the 89 patients in the Intent to Treat Population, 75 patients had data at Week 10 and at Baseline for the blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 10 score minus the Baseline score, thus a negative change from Baseline indicates improvement.

Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment

Of the 89 patients in the Intent to Treat Population, 52 patients had data at Week 54 and at Baseline for blinded assessment, and are included in this summary. Change from Baseline has been calculated as the Week 54 score minus the Baseline score, thus a negative Change from Baseline indicates improvement.

Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment

The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10

The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as non-responders. Percentage is calculated by dividing the number of patients with a CDAI decrease of at least 100 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54

The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 10 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10

The 89 patients from Intent to Treat Population are included in this summary. In case of missing CDAI score, patients are counted as remitters. Percentage is calculated by dividing the number of patients with a CDAI less than or equal to 150 points at Week 54 by the total number of patients in the Intent to Treat Population, multiplied by 100.

Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54

Of the 89 patients in the Intent to Treat Population, 76 patients had plasma level data at Week 10 and are included in this summary.

Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10

Of the 89 patients in the Intent to Treat Population, 76 patients had plasma levels taken at Week 10 and Baseline and are included in this summary. Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.

Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10

Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and are included in this summary.

Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52

Of the 89 patients in the Intent to Treat Population, 51 patients had plasma level data at Week 54 and Baseline and are included in this summary. Ratio was calculated by dividing the Week 54 value by the Baseline value for the patients with data at both timepoints.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.	NCT01295151	Rheumatoid Arth...	Etanercept Abatacept Rituximab Adalimumab Certolizumab Pe... Infliximab Golimumab	18 Years -	University of Leeds
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)	NCT01374971	Rheumatoid Arth...	Certolizumab Pe... Arthroscopic sy...	18 Years -	Arthritis Treatment Center, Maryland
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas	NCT00354367	Crohn Disease	Certolizumab pe...	18 Years -	UCB Pharma
Mucosal Healing Study in Crohn's Disease (CD)	NCT00297648	Crohn's Disease	Certolizumab pe...	18 Years -	UCB Pharma
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)	NCT01374971	Rheumatoid Arth...	Certolizumab Pe... Arthroscopic sy...	18 Years -	Arthritis Treatment Center, Maryland
SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.	NCT01295151	Rheumatoid Arth...	Etanercept Abatacept Rituximab Adalimumab Certolizumab Pe... Infliximab Golimumab	18 Years -	University of Leeds
A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease	NCT00358683	Crohn's Disease	Certolizumab pe...	18 Years -	UCB Pharma
Observation of Treatment With Certolizumab Pegol in Daily Practice	NCT01069419	Rheumatoid Arth...		18 Years -	UCB Pharma
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas	NCT00354367	Crohn Disease	Certolizumab pe...	18 Years -	UCB Pharma
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease	NCT00552058	Crohn Disease	certolizumab pe... Placebo	18 Years - 75 Years	UCB Pharma
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease	NCT00552058	Crohn Disease	certolizumab pe... Placebo	18 Years - 75 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

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