A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00299130
• Date of registration: 03/03/2006
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis SERENE
• Scientific title: A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: October 2005
• Target sample size: 511
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00299130
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Genentech, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:

- Adult patients 18-80 years of age.

- Rheumatoid arthritis (RA) for = 6 months, diagnosed according to the revised 1987
American College of Rheumatology (ACR) criteria for the classification of rheumatoid
arthritis.

- Receiving outpatient treatment for RA.

- Swollen joint count (SJC) = 8 (66 joint count), and tender joint count (TJC) = 8 (68
joint count) at screening and baseline.

- At screening, either

- C-reactive protein (CRP) = 0.6 mg/dL (6 mg/L), or

- Erythrocyte sedimentation rate (ESR) = 28 mm/hour.

- Inadequate response to methotrexate, having received and tolerated at a dose of 10-25
mg/week it for = 12 weeks.

Exclusion criteria:

- Rheumatic autoimmune disease other than RA, or significant systemic involvement
secondary to RA.

- Inflammatory joint disease other than RA, or other systemic autoimmune disorder.

- Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16.

- Surgery within 12 weeks of study or planned within 24 weeks of randomization.

- Previous treatment with any approved or investigational biological agent for RA, an
anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: Methylprednisolone

Drug: Folate

Drug: Placebo

Drug: Rituximab

Primary Outcome(s)

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 [Time Frame: Baseline and Week 24]

Secondary Outcome(s)

Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components) [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Erythrocyte Sedimentation Rate [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Patient's Pain Assessment [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Tender Joint Count [Time Frame: Baseline, Week 24 and Week 48]

Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24 [Time Frame: Week 24]

Percentage of Participants With an ACR50 Response at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24 [Time Frame: Baseline and Week 24]

Percent Change From Baseline in C-Reactive Protein [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores [Time Frame: Baseline, Week 24 and Week 48]

Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24 [Time Frame: Baseline and Week 24]

Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Physician's Global Assessment of Disease Activity [Time Frame: Baseline, Week 24 and Week 48]

Percentage of Participants With an ACR70 Response at Week 48 [Time Frame: Baseline and Week 48]

Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48 [Time Frame: Baseline and Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Swollen Joint Count [Time Frame: Baseline, Week 24 and Week 48]

Percentage of Participants With an ACR50 Response at Week 48 [Time Frame: Baseline and Week 48]

Percentage of Participants With an ACR70 Response at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48 [Time Frame: Week 48]

Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score [Time Frame: Baseline, Week 24 and Week 48]

Percent Change From Baseline in Patient's Global Assessment of Disease Activity [Time Frame: Baseline, Week 24 and Week 48]

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48 [Time Frame: Baseline and Week 48]

Secondary ID(s)

WA17045

U2973g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche

Results

• Results available: Yes
• Date Posted: 28/06/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00299130