A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332994
First received: March 18, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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 ]

Enrollment: 519
Study Start Date: March 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

  Hide Study Locations
Locations
Germany
Aachen, Germany, 52064
Bad Aibling, Germany, 83043
Bad Bramstedt, Germany, 24576
Bad Nauheim, Germany, 61231
Bad Staffelstein, Germany, 96231
Bayreuth, Germany, 95445
Berlin, Germany, 14129
Berlin, Germany, 13055
Berlin, Germany, 12161
Berlin, Germany, 12435
Berlin, Germany, 13125
Berlin, Germany, 10117
Berlin, Germany, 10435
Blaubeuren, Germany, 89143
Bonn, Germany, 53111
Bruchhausen-Vilsen, Germany, 27305
Chemnitz, Germany, 09130
Donaueschingen, Germany, 78166
Dresden, Germany, 01109
Dresden, Germany, 01307
Dresden, Germany, 01097
Dresden, Germany, 01067
Düsseldorf, Germany, 40217
Düsseldorf, Germany, 40225
Erfurt, Germany, 99096
Essen, Germany, 45239
Frankfurt Am Main, Germany, 60590
Freiburg, Germany, 79106
Giessen, Germany, 35392
Gommern, Germany, 39245
Goslar, Germany, 38642
Greifswald, Germany, 17475
Göttingen, Germany, 37075
Halle, Germany, 06108
Halle, Germany, 06128
Halle, Germany, 06120
Hamburg, Germany, 22147
Hamburg, Germany, 22767
Hamburg, Germany, 20246
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Heidelberg, Germany, 69121
Herne, Germany, 44652
Hildesheim, Germany, 31134
Hofheim, Germany, 65719
Jena, Germany, 07747
Kiel, Germany, 24105
Köln, Germany, 50679
Köln, Germany, 50924
Köln, Germany, 51149
Leipzig, Germany, 04103
Leipzig, Germany, 04109
Lingen, Germany, 49808
Ludwigsfelde, Germany, 14974
Mainz, Germany, 55131
Muenchen, Germany, 80336
Mönchengladbach, Germany, 41061
München, Germany, 80335
München, Germany, 81541
Naumburg, Germany, 06628
Naunhof, Germany, 04683
Neuss, Germany, 41460
Neuss, Germany, 41462
Nienburg, Germany, 31582
Olsberg, Germany, 59939
Osnabrück, Germany, 49074
Plochingen, Germany, 73207
Potsdam, Germany, 14469
Ratingen, Germany, 40882
Regensburg, Germany, 93053
Rendsburg, Germany, 24768
Rheine, Germany, 48431
Rostock, Germany, 18059
Saarbruecken, Germany, 66111
Sendenhorst, Germany, 48324
Stuttgart, Germany, 70178
Stuttgart, Germany, 70372
Traunstein, Germany, 83278
Trier, Germany, 54292
Tübingen, Germany, 72076
Ulm, Germany, 89081
Wiesbaden, Germany, 65189
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: April 7, 2014
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 April 15, 2014