A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01235507
First received: October 15, 2010
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Disease Activity Score (DAS28) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
- Number and percentage of patients achieving remission (DAS28 < 2.6) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change in C-reactive protein (CRP) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
- Change in Quality of Life: Health Assessment Questionnaire (HAQ), Medical Outcomes Study Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT) fatigue score, Pain visual analogue scale [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
- Incidence of patients with all-cause discontinuation of RoActemra/Actemra [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 71 |
| Study Start Date: | February 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: tocilizumab [RoActemra/Actemra]
8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
Drug: methotrexate
stable dose as prescribed
|
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 (RA)
- On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
- Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
- Body weight </= 150 kg
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
- Rheumatic autoimmune disease other than RA
- Functional class IV according to American College of Rheumatology (ACR) classification
- Prior history of or current inflammatory joint disease other then RA
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Treatment with any biologic drug that is used in the treatment or RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Positive for HIV
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235507
Locations
| Bosnia and Herzegovina | |
| Banja Luka, Bosnia and Herzegovina, 78 000 | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Tuzla, Bosnia and Herzegovina, 75000 | |
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: | NCT01235507 History of Changes |
| Other Study ID Numbers: | ML25303 |
| Study First Received: | October 15, 2010 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Bosnia: Agency for Drugs and Medical Devices of Bosnia and Herzegovina |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Antirheumatic Agents Methotrexate Therapeutic Uses Pharmacologic Actions Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013