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A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01878318
Recruitment Status : Withdrawn
First Posted : June 14, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: methotrexate Drug: tocilizumab [RoActemra/Actemra] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs
Study Start Date : June 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RoActemra/Actemra Drug: methotrexate
stable dose

Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks, 24 weeks

Primary Outcome Measures :
  1. Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale [ Time Frame: from baseline to Week 24 ]

Secondary Outcome Measures :
  1. Radiological changes in the hand according to the modified Sharp scale [ Time Frame: from baseline to Week 24 ]
  2. Change in Ritchie articular index [ Time Frame: from baseline to Week 24 ]
  3. Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]
  4. Change in pain: Visual analogue scale (VAS) [ Time Frame: from baseline to Week 24 ]
  5. Change in disability: Stanford Health Assessment Questionnaire [ Time Frame: from baseline to Week 24 ]
  6. Change in FACIT-fatigue questionnaire [ Time Frame: from baseline to Week 24 ]
  7. Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: from baseline to Week 28 ]
  8. Change in C-reactive protein [ Time Frame: from baseline to Week 24 ]
  9. Change in immunologic parameters: Rheumatic factor/anti-CCP [ Time Frame: from baseline to Week 24 ]
  10. Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of >/= 6 months duration
  • Active moderate to severe rheumatoid arthritis (DAS >/= 3.2)
  • Swollen joint count (SJC) >/= 6, tender joint count >/= 8
  • Synovitis in the dominant hand
  • Inadequate response to stable dose of a non-biological DMARD for at least 3 months
  • Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
  • Patient on outpatient treatment

Exclusion Criteria:

  • Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • American College of Rheumatology (ACR) functional class IV
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  • Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
  • Inadequate hematologic, renal or liver function
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Pregnant or lactating women
  • History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
  • Current infections or history of recurrent infections
  • History of or currently active primary or acquired immunodeficiency
  • Active tuberculosis requiring treatment in the previous 3 years
  • Body weight > 150 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01878318

Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01878318    
Other Study ID Numbers: ML28204
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors