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A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01283971
First received: January 25, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks or adalimumab 40 mg sc every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: tocilizumab [RoActemra/Actemra]
Drug: adalimumab
Drug: Placebo
Drug: methotrexate
Drug: folate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Clinical remission: Disease activity score (DAS28) <2.6 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy according to American College of Rheumatology (ACR) criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Efficacy according to European League Against Rheumatism (EULAR) criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving low disease activity (DAS28 <3.2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life: Health Assessment Questionnaire (HAQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life: Short-Form-36 (SF-36) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life: Routine Assessment of Patient Index Data (RAPID3) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in hemoglobin levels [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 24 weeks
Drug: Placebo
adalimumab-placebo sc every 2 weeks, 24 weeks
Drug: methotrexate
10-25 mg weekly
Drug: folate
>/= 5 mg weekly
Active Comparator: B Drug: adalimumab
40 mg sc every 2 weeks, 24 weeks
Drug: Placebo
tocilizumab placebo iv every 4 weeks, 24 weeks
Drug: methotrexate
10-25 mg weekly
Drug: folate
>/= 5 mg weekly

  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
  • Rheumatoid arthritis of >/= 6 months duration (according to ACR criteria)
  • Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved TNF-agent other than adalimumab. Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
  • On methotrexate treatment for >/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
  • Disease Activity Score (DAS28) >3.2 at baseline
  • Oral corticosteroids (</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for >/=6 weeks prior to baseline

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis
  • Functional class IV (ACR criteria)
  • History of severe allergic reaction to human, humanized or murine monoclonal antibodies
  • Known active current or history of recurrent infection (including tuberculosis)
  • Primary or secondary immunodeficiency (history of or currently active)
  • Body weight >150 kg
  • Previous treatment with any cell-depleting therapies
  • Previous treatment with tocilizumab
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283971

  Show 170 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: NCT01283971     History of Changes
Other Study ID Numbers: MA25522, 2010-023587-40
Study First Received: January 25, 2011
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013