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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332994
First received: March 18, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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: July 2015
Estimated Primary Completion Date: July 2015 (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

Contacts
Contact: Please reference Study ID Number: ML22985 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 85 Study Locations
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 13, 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 16, 2013