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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01592292
Date of registration: 11/04/2012
Prospective Registration: No
Primary sponsor: Hoffmann-La Roche
Public title: An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
Scientific title: A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
Date of first enrolment: November 2011
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01592292
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Korea, Republic of
Contacts
Name:     Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  Hoffmann-La Roche
Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult participants, >/=20 years of age

- Participants with rheumatoid arthritis, who have not responded or have been intolerant
to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative
anti-TNF alpha therapy

Exclusion Criteria:

- Participants whose first anti-TNF alpha treatment was, or second biological therapy is
given as part of a clinical trial studying rheumatoid arthritis

- Participants who have not signed the informed consent form



Age minimum: 20 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Adalimumab
Drug: Etanercept
Drug: Infliximab
Drug: Rituximab
Primary Outcome(s)
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population [Time Frame: Baseline and Month 6]
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) [Time Frame: Baseline and Month 6]
Secondary Outcome(s)
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population [Time Frame: Month 6]
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) [Time Frame: Month 6]
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in DAS28 at Month 12 [Time Frame: Baseline and Month 12]
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population [Time Frame: Baseline, Month 6 and 12]
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) [Time Frame: Baseline, Month 6 and 12]
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events [Time Frame: Baseline up to Month 12]
Secondary ID(s)
ML27923
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 22/08/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01592292
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