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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01641952
• Date of registration: 13/07/2012
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: 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
• Scientific 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
• Date of first enrolment: October 2011
• Target sample size: 505
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01641952
• Study type: Observational
• Phase: N/A

Countries of recruitment

Romania

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment [Time Frame: Week 20]

Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course [Time Frame: Week 20]

Change From Baseline in DAS28-ESR at Week 20 [Time Frame: Baseline and Week 20]

Percentage of Participants With EULAR Response [Time Frame: Week 20]

Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria [Time Frame: Week 20]

Mean DAS28-ESR Score at Visit 4 (Week 20) [Time Frame: Week 20]

Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously [Time Frame: Week 20]

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 [Time Frame: Week 20]

Number of Participants With Adverse Events (AE) [Time Frame: Up to 39 months]

Secondary Outcome(s)

Health Assessment Questionnaire (HAQ) Score at Week 20 [Time Frame: Baseline and Week 20]

Secondary ID(s)

ML27953

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01641952