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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

Primary Purpose

Rheumatoid Arthritis

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
methotrexate
tocilizumab [RoActemra/Actemra]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    RoActemra/Actemra

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale

    Secondary Outcome Measures

    Radiological changes in the hand according to the modified Sharp scale
    Change in Ritchie articular index
    Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24
    Change in pain: Visual analogue scale (VAS)
    Change in disability: Stanford Health Assessment Questionnaire
    Change in FACIT-fatigue questionnaire
    Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)
    Change in C-reactive protein
    Change in immunologic parameters: Rheumatic factor/anti-CCP
    Safety: Incidence of adverse events

    Full Information

    First Posted
    June 6, 2013
    Last Updated
    November 1, 2016
    Sponsor
    Hoffmann-La Roche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01878318
    Brief Title
    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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hoffmann-La Roche

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RoActemra/Actemra
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    methotrexate
    Intervention Description
    stable dose
    Intervention Type
    Drug
    Intervention Name(s)
    tocilizumab [RoActemra/Actemra]
    Intervention Description
    8 mg/kg intravenously every 4 weeks, 24 weeks
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Radiological changes in the hand according to the modified Sharp scale
    Time Frame
    from baseline to Week 24
    Title
    Change in Ritchie articular index
    Time Frame
    from baseline to Week 24
    Title
    Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24
    Time Frame
    Weeks 12 and 24
    Title
    Change in pain: Visual analogue scale (VAS)
    Time Frame
    from baseline to Week 24
    Title
    Change in disability: Stanford Health Assessment Questionnaire
    Time Frame
    from baseline to Week 24
    Title
    Change in FACIT-fatigue questionnaire
    Time Frame
    from baseline to Week 24
    Title
    Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)
    Time Frame
    from baseline to Week 28
    Title
    Change in C-reactive protein
    Time Frame
    from baseline to Week 24
    Title
    Change in immunologic parameters: Rheumatic factor/anti-CCP
    Time Frame
    from baseline to Week 24
    Title
    Safety: Incidence of adverse events
    Time Frame
    approximately 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Trials
    Organizational Affiliation
    Hoffmann-La Roche
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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

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