An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01592292
First received: April 11, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in patients with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Patients have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change in Disease Activity Score (DAS) 28 [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
- Mean change over time in tender joint count (TJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
- Mean change over time in swollen joint count (SJC) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
- Mean change over time in erythrocyte sedimentation rate (ESR) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
- Mean Quality of Life score [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy
Criteria
Inclusion Criteria:
- Adult patients, >/=20 years of age
- Patients 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:
- Patients whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Patients who have not signed the informed consent form
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592292
Contacts
| Contact: Please reference Study ID Number: ML27923 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| Busan, Korea, Republic of | |
| Recruiting | |
| Daegu, Korea, Republic of, 705-718 | |
| Recruiting | |
| Daegu, Korea, Republic of, 700-712 | |
| Terminated | |
| Daejeon, Korea, Republic of, 302-799 | |
| Recruiting | |
| Goyang-si, Korea, Republic of, 411-706 | |
| Recruiting | |
| Jeju, Korea, Republic of, 690-767 | |
| Terminated | |
| Jeonju, Korea, Republic of, 561-712 | |
| Recruiting | |
| Kwangju, Korea, Republic of, 501-757 | |
| Recruiting | |
| Seoul, Korea, Republic of, 130-702 | |
| Recruiting | |
| Seoul, Korea, Republic of, 150-713 | |
| Recruiting | |
| Seoul, Korea, Republic of, 143-729 | |
| Recruiting | |
| Seoul, Korea, Republic of, 134-722 | |
| Recruiting | |
| Suwon, Korea, Republic of, 442-723 | |
| Recruiting | |
| Ulsan, Korea, Republic of, 682-714 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01592292 History of Changes |
| Other Study ID Numbers: | ML27923 |
| Study First Received: | April 11, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013