A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502840
First received: July 17, 2007
Last updated: May 23, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: rituximab [MabThera/Rituxan] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070). |
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:
- Change of DAS 28 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ACR 20/50/70, HAQ, SF-36, FACIT-F, TJC, SJC, CRP, BSG, RF. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 194 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
- eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
Exclusion Criteria:
- patients who have withdrawn from treatment in ML19070 pre-week 16;
- patients with a previous response in DAS28 <0.6 to MabThera after week 16;
- concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502840
Hide Study Locations
Hide Study LocationsLocations
| Germany | |
| Bad Aibling, Germany, 83043 | |
| Bad Bramstedt, Germany, 24576 | |
| Berlin, Germany, 13055 | |
| Berlin, Germany, 14163 | |
| Berlin, Germany, 13589 | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, 13125 | |
| Bonn, Germany, 53111 | |
| Cuxhaven, Germany, 27476 | |
| Donaueschingen, Germany, 78166 | |
| Dresden, Germany, 01109 | |
| Erfurt, Germany, 99096 | |
| Erlangen, Germany, 91054 | |
| Essen, Germany, 45239 | |
| Frankfurt Am Main, Germany, 60590 | |
| Freiburg, Germany, 79106 | |
| Fulda, Germany, 36039 | |
| Gießen, Germany, 35392 | |
| Gommern, Germany, 39245 | |
| Hagen, Germany, 58135 | |
| Halle, Germany, 06120 | |
| Hamburg, Germany, 22081 | |
| Hannover, Germany, 30625 | |
| Heidelberg, Germany, 69120 | |
| Herne, Germany, 44652 | |
| Homburg/Saar, Germany, 66424 | |
| Jena, Germany, 07747 | |
| Karlsruhe, Germany, 76137 | |
| Köln, Germany, 50924 | |
| Ludwigshafen, Germany, 67063 | |
| Mittelherwigsdorf, Germany, 02763 | |
| Muenchen, Germany, 80336 | |
| München, Germany, 80335 | |
| München, Germany, 81541 | |
| Münster, Germany, 48149 | |
| Naunhof, Germany, 04683 | |
| Oldenburg, Germany, 26122 | |
| Osnabrück, Germany, 49074 | |
| Pirna, Germany, 01796 | |
| Ratingen, Germany, 40882 | |
| Regensburg, Germany, 93053 | |
| Rostock, Germany, 18059 | |
| Sendenhorst, Germany, 48324 | |
| Stuttgart, Germany, 70178 | |
| Treuenbrietzen, Germany, 14929 | |
| Tübingen, Germany, 72076 | |
| Ulm, Germany, 89081 | |
| Wiesbaden, Germany, 65189 | |
| Wuerzburg, Germany, 97080 | |
| Würselen, Germany, 52146 | |
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: | NCT00502840 History of Changes |
| Other Study ID Numbers: | ML19071 |
| Study First Received: | July 17, 2007 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
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 23, 2013