A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Last updated: June 22, 2015
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT01587989
ML27837
2011-001863-39
  • Ages > 18
  • All Genders

Study Summary

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients, >/= 18 years of age

  • Rheumatoid arthritis of >/= 1 year duration

  • Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)

  • On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1

  • Body weight </= 150 kg

  • Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25out of 28 days prior to baseline

Exclusion

Exclusion Criteria:

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

  • Rheumatic autoimmune disease other than rheumatoid arthritis

  • Functional class IV American College of Rheumatology (ACR) Classification

  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis

  • Treatment with a biologic agent at any time prior to baseline

  • Treatment with traditional DMARDs other than methotrexate within 1 month (forleflunomide 3 months) prior to baseline

  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

  • Previous treatment with tocilizumab

  • Pregnant or lactating women

  • Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel diseasewhere flares are commonly treated with oral or parenteral corticosteroids

  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterialor other infections

  • History of or currently active primary or secondary immunodeficiency

  • Evidence of active malignant disease, malignancies diagnosed within the previous 5years

  • Active tuberculosis requiring treatment within the previous 3 years

  • Positive for HIV infection

Study Design

Total Participants: 77
Study Start date:
February 01, 2012
Estimated Completion Date:
February 28, 2014

Connect with a study center

  • Graz, 8036
    Austria

    Site Not Available

  • Graz-Eggenberg, 8020
    Austria

    Site Not Available

  • Hollabrunn, 2020
    Austria

    Site Not Available

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Linz, 4020
    Austria

    Site Not Available

  • Salzburg, 5020
    Austria

    Site Not Available

  • Stockerau, 2000
    Austria

    Site Not Available

  • Wels, 4600
    Austria

    Site Not Available

  • Wien, 1160
    Austria

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.