A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis
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:
NCT01332994
First received: March 18, 2011
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: rituximab [MabThera/Rituxan] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Early efficacy rate defined as Disease Activity Score (DAS28) remission <2.6 after 4 courses of TCZ treatment [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of Disease Activity Score (DAS28) remission <2.6 at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
- Response rate according to European League Against Rheumatism (EULAR) criteria [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
- Response rate according to American College of Rheumatology (ACR) criteria [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
- Quality of life: Short Form (36) Health Survey [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Quality of life: Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Quality of life: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 12 weeks.
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
|
| Experimental: 2 |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 12 weeks.
Drug: rituximab [MabThera/Rituxan]
1 g intravenously at Week 16 and 18
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients >/=18 years of age
- Body weight < /=130kg
- Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
- Disease Activity Score (DAS28) of >3.2
- Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
- Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline
Exclusion Criteria:
- Prior treatment with TNF-inhibitors or other biologic DMARD
- Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
- Functional class IV (American College of Rheumatology classification)
- Rheumatic autoimmune disease other than rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332994
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Contacts
| Contact: Reference Study ID Number: ML22985 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Hide Study LocationsLocations
| Germany | |
| Active, not recruiting | |
| Aachen, Germany, 52064 | |
| Recruiting | |
| Bad Aibling, Germany, 83043 | |
| Completed | |
| Bad Bramstedt, Germany, 24576 | |
| Completed | |
| Bad Nauheim, Germany, 61231 | |
| Terminated | |
| Bad Staffelstein, Germany, 96231 | |
| Completed | |
| Bayreuth, Germany, 95445 | |
| Active, not recruiting | |
| Berlin, Germany, 13125 | |
| Recruiting | |
| Berlin, Germany, 10435 | |
| Terminated | |
| Berlin, Germany, 12435 | |
| Completed | |
| Berlin, Germany, 12161 | |
| Active, not recruiting | |
| Berlin, Germany, 10117 | |
| Completed | |
| Berlin, Germany, 13055 | |
| Terminated | |
| Berlin, Germany, 14129 | |
| Active, not recruiting | |
| Berlin, Germany, 12161 | |
| Completed | |
| Blaubeuren, Germany, 89143 | |
| Completed | |
| Bonn, Germany, 53111 | |
| Recruiting | |
| Bruchhausen-Vilsen, Germany, 27305 | |
| Recruiting | |
| Chemnitz, Germany, 09130 | |
| Completed | |
| Donaueschingen, Germany, 78166 | |
| Recruiting | |
| Dresden, Germany, 01307 | |
| Completed | |
| Dresden, Germany, 01097 | |
| Active, not recruiting | |
| Dresden, Germany, 01067 | |
| Active, not recruiting | |
| Dresden, Germany, 01109 | |
| Terminated | |
| Düsseldorf, Germany, 40217 | |
| Completed | |
| Düsseldorf, Germany, 40225 | |
| Active, not recruiting | |
| Erfurt, Germany, 99096 | |
| Completed | |
| Essen, Germany, 45239 | |
| Active, not recruiting | |
| Frankfurt Am Main, Germany, 60590 | |
| Completed | |
| Freiburg, Germany, 79106 | |
| Active, not recruiting | |
| Giessen, Germany, 35392 | |
| Completed | |
| Gommern, Germany, 39245 | |
| Active, not recruiting | |
| Goslar, Germany, 38642 | |
| Active, not recruiting | |
| Greifswald, Germany, 17475 | |
| Active, not recruiting | |
| Göttingen, Germany, 37075 | |
| Recruiting | |
| Halle, Germany, 06120 | |
| Active, not recruiting | |
| Halle, Germany, 06128 | |
| Completed | |
| Halle, Germany, 06108 | |
| Completed | |
| Hamburg, Germany, 22767 | |
| Completed | |
| Hamburg, Germany, 20251 | |
| Completed | |
| Hamburg, Germany, 22147 | |
| Completed | |
| Hannover, Germany, 30625 | |
| Completed | |
| Heidelberg, Germany, 69120 | |
| Active, not recruiting | |
| Heidelberg, Germany, 69121 | |
| Active, not recruiting | |
| Herne, Germany, 44652 | |
| Active, not recruiting | |
| Hildesheim, Germany, 31134 | |
| Terminated | |
| Hofheim, Germany, 65719 | |
| Active, not recruiting | |
| Jena, Germany, 07747 | |
| Active, not recruiting | |
| Kiel, Germany, 24105 | |
| Terminated | |
| Köln, Germany, 51149 | |
| Completed | |
| Köln, Germany, 50679 | |
| Active, not recruiting | |
| Köln, Germany, 50924 | |
| Completed | |
| Leipzig, Germany, 04109 | |
| Recruiting | |
| Leipzig, Germany, 04103 | |
| Active, not recruiting | |
| Lingen, Germany, 49808 | |
| Active, not recruiting | |
| Ludwigsfelde, Germany, 14974 | |
| Active, not recruiting | |
| Mainz, Germany, 55131 | |
| Completed | |
| Mainz, Germany, 55131 | |
| Active, not recruiting | |
| Muenchen, Germany, 80336 | |
| Completed | |
| Mönchengladbach, Germany, 41061 | |
| Active, not recruiting | |
| München, Germany, 80335 | |
| Active, not recruiting | |
| München, Germany, 81541 | |
| Active, not recruiting | |
| Naumburg, Germany, 06628 | |
| Active, not recruiting | |
| Naunhof, Germany, 04683 | |
| Completed | |
| Neuss, Germany, 41460 | |
| Completed | |
| Neuss, Germany, 41462 | |
| Completed | |
| Nienburg, Germany, 31582 | |
| Active, not recruiting | |
| Olsberg, Germany, 59939 | |
| Active, not recruiting | |
| Osnabrück, Germany, 49074 | |
| Completed | |
| Plochingen, Germany, 73207 | |
| Completed | |
| Potsdam, Germany, 14469 | |
| Active, not recruiting | |
| Ratingen, Germany, 40882 | |
| Completed | |
| Regensburg, Germany, 93053 | |
| Active, not recruiting | |
| Rendsburg, Germany, 24768 | |
| Active, not recruiting | |
| Rheine, Germany, 48431 | |
| Active, not recruiting | |
| Rostock, Germany, 18059 | |
| Completed | |
| Saarbruecken, Germany, 66111 | |
| Completed | |
| Sendenhorst, Germany, 48324 | |
| Active, not recruiting | |
| Stuttgart, Germany, 70372 | |
| Active, not recruiting | |
| Stuttgart, Germany, 70178 | |
| Active, not recruiting | |
| Traunstein, Germany, 83278 | |
| Completed | |
| Trier, Germany, 54292 | |
| Active, not recruiting | |
| Tübingen, Germany, 72076 | |
| Completed | |
| Ulm, Germany, 89081 | |
| Completed | |
| Wiesbaden, Germany, 65189 | |
| Active, not recruiting | |
| Wuerzburg, Germany, 97080 | |
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: | NCT01332994 History of Changes |
| Other Study ID Numbers: | ML22985 |
| Study First Received: | March 18, 2011 |
| 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