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

March 18, 2011
April 7, 2014
March 2011
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01332994 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Drug: tocilizumab [RoActemra/Actemra]
    8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
  • Experimental: 1
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: tocilizumab [RoActemra/Actemra]
  • Experimental: 2
    Interventions:
    • Drug: tocilizumab [RoActemra/Actemra]
    • Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
519
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01332994
ML22985
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP