A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
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:
NCT01399697
First received: July 20, 2011
Last updated: May 7, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: methotrexate Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change in disease activity (DAS28) score [ Time Frame: from Week 16 to Week 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients achieving DAS28 remission (DAS28 < 2.6) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Proportion of patients achieving clinical disease activity index (CDAI) remission (CDAI < 2.8) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Proportion of patients achieving simplified disease activity index (SDAI) remission (SDAI < 3.3) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
- Physical function: Health assessment questionnaire (HAQ) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
- Physical function: Short-form health survey (SF-12) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
- Physical function: Visual analogue scale fatigue (VAS Fatigue) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 237 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
Drug: methotrexate
orally, Week 1 - 16
Drug: methotrexate
orally, Week 17-28
|
| Active Comparator: B |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
Drug: methotrexate
orally, Week 1 - 16
Drug: placebo
methotrexate placebo orally, Week 17-28
|
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
- Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
- Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- Body weight < 150 kg
- Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day
Exclusion Criteria:
- Pregnant or nursing women
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than RA
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- Prior history of or current inflammatory joint disease other than RA
- Treatment with a biologic agent at any time prior to baseline
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399697
Show 53 Study Locations
Contacts
| Contact: Please reference Study ID Number: ML27828 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Show 53 Study LocationsSponsors 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: | NCT01399697 History of Changes |
| Other Study ID Numbers: | ML27828 |
| Study First Received: | July 20, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Spain: Agencia Espanola del Medicamento y Productos Sanitarios (AEMPS) |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate 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 |
ClinicalTrials.gov processed this record on May 16, 2013