Clinical trial NCT02079532: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Official title: An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* rheumatoid arthritis for \>=6 months;
* previous inadequate response to a single anti-TNF alpha inhibitor;
* methotrexate at a stable dose range 7.5-25 mg/week.

Exclusion Criteria:

* other chronic inflammatory articular disease or systemic autoimmune disease;
* previous treatment with MabThera or intolerance to MabThera;
* corticosteroids\>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;

Primary outcomes:
measure: Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Week 24
Secondary outcomes:
measure: DAS28 Score
timeFrame: Screening and Weeks 8, 16, and 24
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate
timeFrame: Weeks 8, 16, and 24
measure: Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving a Response By EULAR Category
timeFrame: Weeks 8, 16, and 24
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Screening and Weeks 8, 16, and 24
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
timeFrame: Screening and Weeks 8, 16, and 24
measure: Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)
timeFrame: Screening and Weeks 8, 16, and 24
measure: SF-36 Domain Scores
timeFrame: Screening and Weeks 8, 16, and 24
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)
timeFrame: Weeks 8, 16, and 24
measure: Swollen Joint Count (SJC)
timeFrame: Screening and Weeks 8, 16, and 24
measure: Tender Joint Count (TJC)
timeFrame: Screening and Weeks 8, 16, and 24
measure: Physician's Global Assessment of Disease Activity
timeFrame: Screening and Weeks 8, 16, and 24
measure: Patient's Assessment of Disease Activity
timeFrame: Screening and Weeks 8, 16, and 24
measure: Patient's Assessment of Pain
timeFrame: Screening and Weeks 8, 16, and 24
measure: C-Reactive Protein (CRP)
timeFrame: Screening, Days 1 and 15, and Weeks 8, 16, and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Screening, Days 1 and 15, and Weeks 8, 16, and 24
measure: Rheumatoid Factor (RF)
timeFrame: Screening and Weeks 8, 16, and 24
Other outcomes:
Locations:
city: Bad Abbach
country: Germany
city: Bad Aibling
country: Germany
city: Bad Bramstedt
country: Germany
city: Bamberg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Bremen
country: Germany
city: Cuxhaven
country: Germany
city: Damp
country: Germany
city: Donaueschingen
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Essen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Fulda
country: Germany
city: GIEßEN
country: Germany
city: Gommern
country: Germany
city: Göttingen
country: Germany
city: Hagen
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Hofheim
country: Germany
city: Homburg/saar
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Köln
country: Germany
city: Ludwigshafen
country: Germany
city: Mainz
country: Germany
city: Mainz
country: Germany
city: Mittelherwigsdorf
country: Germany
city: Muenchen
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Naunhof
country: Germany
city: Oldenburg
country: Germany
city: Osnabrück
country: Germany
city: Pirna
country: Germany
city: Ratingen
country: Germany
city: Rostock
country: Germany
city: Schwerte
country: Germany
city: Sendenhorst
country: Germany
city: Stuttgart
country: Germany
city: Treuenbrietzen
country: Germany
city: Trier
country: Germany
city: Tübingen
country: Germany
city: ULM
country: Germany
city: Wiesbaden
country: Germany
city: Wiesbaden
country: Germany
city: Wuerzburg
country: Germany
city: Wuppertal
country: Germany
city: Würselen
country: Germany
city: Zeven
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: