Clinical trial NCT00462345: A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Official title: An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* rheumatoid arthritis for \>=6 months;
* receiving outpatient treatment;
* an inadequate response to at least one anti-TNF therapy;
* stable methotrexate for \>=12 weeks.

Exclusion Criteria:

* other rheumatic autoimmune disease or inflammatory joint disease;
* previous treatment with MabThera;
* concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.

Primary outcomes:
measure: Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24
timeFrame: Week 24
measure: Disease Activity Score Based on 28-Joint Count (DAS-28)
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2
timeFrame: Baseline, Week 24
measure: Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24
timeFrame: Week 24
measure: Swollen Join Count (SJC)
timeFrame: Baseline, Weeks 24 and 48
measure: Tender Joint Count (TJC)
timeFrame: Baseline, Weeks 24 and 48
measure: Patient Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, Weeks 24 and 48
measure: Physician Global Assessment of Disease Activity (VAS)
timeFrame: Baseline, Weeks 24 and 48
measure: Patient Assessment of Pain (VAS)
timeFrame: Baseline, Weeks 24 and 48
measure: C-reactive Protein (CRP) Level
timeFrame: Baseline, Weeks 24 and 48
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 24 and 48
measure: HAQ-DI Score
timeFrame: Baseline, Weeks 24 and 48
measure: Physical Function as Assessed by Short Form 36 (SF-36)
timeFrame: Screening, Weeks 24 and 48
measure: SF-36 Mental Component Scores
timeFrame: Screening, Weeks 24 and 48
measure: Modified Total Sharp-Genant Score (mTSS)
timeFrame: Screening and Weeks 24 and 48
measure: Modified Sharp Radiographic Erosion Score (ES)
timeFrame: Screening, Weeks 24 and 48
measure: Modified Sharp Radiographic Joint Space Narrowing Score (JSN)
timeFrame: Screening, Weeks 24 and 48
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.