An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01557348
• Date of registration: 13/03/2012
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
• Scientific title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.
• Date of first enrolment: June 2009
• Target sample size: 1239
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01557348
• Study type: Observational
• Phase: N/A

Countries of recruitment

Canada, Colombia, France, Germany, Greece, Italy, Mexico, Monaco, Norway, Portugal, Spain, United Kingdom

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant
to a single TNF-inhibitor therapy

- Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy,
in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

- Patients whose second biologic therapy is given as part of a clinical trial studying
RA treatment



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Primary Outcome(s)

Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6 [Time Frame: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6]

Secondary Outcome(s)

Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12 [Time Frame: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12]

Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Number of Participants With Reasons for Discontinuation of the First TNFi Therapy [Time Frame: Day 1 (Study entry visit)]

Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi [Time Frame: Baseline]

Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice [Time Frame: Up to 12 months]

Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy [Time Frame: Day 1 (Study entry visit)]

Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy [Time Frame: Month 6 and Month 12]

Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death [Time Frame: Up to 12 Months]

Least Squares Mean Change From Baseline in TJC at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Least Squares Mean Change From Baseline in ESR at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Least Squares Mean Change From Baseline in SJC at Months 6 and 12 [Time Frame: Baseline, Month 6, and Month 12]

Number of Participants With Previous TNFi Therapy [Time Frame: Day 1 (Study entry visit)]

Secondary ID(s)

MA22401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01557348