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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

Page last updated: December 08, 2011

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