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)

Last updated: November 3, 2014
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT01235507
ML25303
  • Ages > 18
  • All Genders

Study Summary

This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.

Eligibility Criteria

Inclusion

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 doseof at least 15 mg/week for at least 6 weeks

  • Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (orequivalent) for at least 25 out of 28 days prior to first dose of study drug

  • Body weight </= 150 kg

Exclusion

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor 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 (forleflunomide 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

Study Design

Total Participants: 71
Study Start date:
February 01, 2011
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Banja Luka, 78 000
    Bosnia and Herzegovina

    Site Not Available

  • Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

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