A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

Last updated: July 17, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT01063062
ML22725
  • Ages > 18
  • All Genders

Study Summary

This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA). Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD). Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment was 24 weeks. The target sample size was 50-200 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients ≥ 18 years of age

  • Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as aDisease Activity Score (DAS28) > 3.2 at screening)

  • Patients with active RA after more than 12 weeks of treatment with DMARDs

  • Patients with inadequate response to a stable dose of non-biologic DMARD

Exclusion

Exclusion Criteria:

  • Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis andable to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA arepermitted

  • Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following enrollment

  • Prior history of or current inflammatory joint disease other than RA

Study Design

Total Participants: 107
Study Start date:
February 28, 2010
Estimated Completion Date:
January 17, 2011

Connect with a study center

  • Alexandria University

    Alexandria,
    Egypt

    Site Not Available

  • Alexandria University Hospital; Rheumatology

    Alexandria,
    Egypt

    Site Not Available

  • Banha Educational Hospital; Rheumatology

    Banha,
    Egypt

    Site Not Available

  • Ain Shams University Hospital; Rheumatology

    Cairo,
    Egypt

    Site Not Available

  • Bab El Sheereya Hospital; Rheumatology

    Cairo,
    Egypt

    Site Not Available

  • El Hussein University Hospital; Rheumatology

    Cairo,
    Egypt

    Site Not Available

  • Kasr El Ainy Hospital

    Cairo,
    Egypt

    Site Not Available

  • Kasr El Ainy Hospital; Rheumatology

    Cairo, 11562
    Egypt

    Site Not Available

  • Manial Specialized Hospital; Rheumatology

    Cairo,
    Egypt

    Site Not Available

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