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)
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: tocilizumab [RoActemra/Actemra] (Drug); methotrexate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Overall contact:
Please reference Study ID Number: ML25303, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety: Incidence of adverse events
Secondary outcome: Change in Disease Activity Score (DAS28)Number and percentage of patients achieving remission (DAS28 < 2.6) Change in C-reactive protein (CRP) 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 Incidence of patients with all-cause discontinuation of RoActemra/Actemra
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
equivalent) for at least 25 out of 28 days prior to first dose of study drug
- Body weight
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
Locations and Contacts
Please reference Study ID Number: ML25303, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
Sarajevo 71000, Bosnia and Herzegovina; Recruiting
Additional Information
Starting date: February 2011
Last updated: December 5, 2011
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