Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01878318
Recruitment Status : Withdrawn
First Posted : June 14, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 14, 2013
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2013)
  • Radiological changes in the hand according to the modified Sharp scale [ Time Frame: from baseline to Week 24 ]
  • Change in Ritchie articular index [ Time Frame: from baseline to Week 24 ]
  • Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]
  • Change in pain: Visual analogue scale (VAS) [ Time Frame: from baseline to Week 24 ]
  • Change in disability: Stanford Health Assessment Questionnaire [ Time Frame: from baseline to Week 24 ]
  • Change in FACIT-fatigue questionnaire [ Time Frame: from baseline to Week 24 ]
  • Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: from baseline to Week 28 ]
  • Change in C-reactive protein [ Time Frame: from baseline to Week 24 ]
  • Change in immunologic parameters: Rheumatic factor/anti-CCP [ Time Frame: from baseline to Week 24 ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: methotrexate
    stable dose
  • Drug: tocilizumab [RoActemra/Actemra]
    8 mg/kg intravenously every 4 weeks, 24 weeks
Study Arms  ICMJE Experimental: RoActemra/Actemra
Interventions:
  • Drug: methotrexate
  • Drug: tocilizumab [RoActemra/Actemra]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 13, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2013)
58
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Venezuela
 
Administrative Information
NCT Number  ICMJE NCT01878318
Other Study ID Numbers  ICMJE ML28204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP