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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: March 12, 2012
Last updated: February 5, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: methotrexate
Drug: placebo
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity DAS28 score from Week 12 (time of randomization) to Week 24 [ Time Frame: from Week 12 to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who achieve DAS28 remission (DAS28 <2.6) at 24 weeks [ Time Frame: approximately 24 Weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with Clinical Disease Activity Index remission (CDAI < 2.8) at 24 weeks [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with Simplified Disease Activity Index remission (SDAI < 3.3) at 24 weeks [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with Rheumatoid Arthritis Disease Activity Index remission (RADAI-5 score 0 to 1.4) at 24 weeks [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Change in quality of life: HAQ-DI/SF-12/VAS Fatigue/VAS Pain questionnaires [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 weeks ] [ Designated as safety issue: No ]
  • Patient's satisfaction with treatment: Treatment Satisfaction Questionnaire for Medication [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Methotrexate Drug: methotrexate
15-25 mg orally weekly, Weeks 1-12
Drug: methotrexate
15-25 mg orally weekly, Weeks 13-24
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 24 weeks
Experimental: B Methotrexate Placebo Drug: methotrexate
15-25 mg orally weekly, Weeks 1-12
Drug: placebo
methotrexate placebo orally weekly, Weeks 13-24
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 24 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 25 out of 28 days prior to baseline

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major 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 (for leflunomide 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 disease where flares are commonly treated with oral or parenteral corticosteroids
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • History of or currently active primary or secondary immunodeficiency
  • Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01587989

Graz, Austria, 8036
Graz-Eggenberg, Austria, 8020
Hollabrunn, Austria, 2020
Innsbruck, Austria, 6020
Linz, Austria, 4020
Salzburg, Austria, 5020
Stockerau, Austria, 2000
Wels, Austria, 4600
Wien, Austria, 1130
Wien, Austria, 1100
Wien, Austria, 1140
Wien, Austria, 1090
Wien, Austria, 1160
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01587989     History of Changes
Other Study ID Numbers: ML27837, 2011-001863-39
Study First Received: March 12, 2012
Last Updated: February 5, 2015
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015