Clinical trial NCT01641952: An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent
Official title: Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan

Brief summary: This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
* Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) \<1.2 or DAS28-ESR \>3.5 at 5 months after first course of anti-TNF therapy
* Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included

Exclusion Criteria:

* More than one previous anti-TNF therapies
* Any other biological therapy apart from the one anti-TNF therapy
* Hypersensitivity to rituximab or any of the excipients or to murine proteins
* Active severe infections
* Participants in a severely immunocompromised state
* Severe heart failure \[New York Heart Association (NYHA) Class IV\] or severe, uncontrolled cardiac disease
* Women of childbearing potential not willing to use contraception
* Pregnant or breastfeeding women
* Participation in another trial

Primary outcomes:
measure: Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria
timeFrame: Week 20
measure: Change From Baseline in DAS28-ESR at Week 20
timeFrame: Baseline and Week 20
measure: Mean DAS28-ESR Score at Visit 4 (Week 20)
timeFrame: Week 20
measure: Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment
timeFrame: Week 20
measure: Percentage of Participants With EULAR Response
timeFrame: Week 20
measure: Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously
timeFrame: Week 20
measure: Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course
timeFrame: Week 20
measure: Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab
timeFrame: Week 20
measure: Number of Participants With Adverse Events (AE)
timeFrame: Up to 39 months
Secondary outcomes:
measure: Health Assessment Questionnaire (HAQ) Score at Week 20
timeFrame: Baseline and Week 20
Other outcomes:
Locations:
city: Bucuresti
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: