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An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01741688
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : October 12, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date November 30, 2012
First Posted Date December 5, 2012
Results First Submitted Date July 23, 2015
Results First Posted Date October 12, 2015
Last Update Posted Date August 1, 2017
Actual Study Start Date October 26, 2012
Actual Primary Completion Date March 6, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2015)
Number of Participants on Tocilizumab at 6 Months After Treatment Initiation [ Time Frame: At 6 months ]
Original Primary Outcome Measures
 (submitted: December 3, 2012)
Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation [ Time Frame: approximately 14 months ]
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2016)
  • Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis [ Time Frame: At baseline ]
    Systemic manifestation measured by C-reactive protein levels > 3
  • Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure [ Time Frame: At baseline ]
    DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab.
  • Number of Participants Starting Tocilizumab After Failing Other Biologic Agents [ Time Frame: At baseline ]
    Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.
  • Median Dose at 6 Months [ Time Frame: At 6 months ]
  • Number of Participants With Dose Modifications at 6 Months [ Time Frame: At 6 months ]
  • Median Duration of Treatment [ Time Frame: Approximately 16 months ]
  • Percentage of Participants Discontinued From Tocilizumab for Safety [ Time Frame: Approximately 16 months ]
    Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.
  • Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy [ Time Frame: Approximately 16 months ]
    Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.
  • Number of Participants Discontinued From Tocilizumab for Other Reasons [ Time Frame: Approximately 16 months ]
    This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.
  • Time to Restoration of Initial Dosing Regimen [ Time Frame: Approximately 16 months ]
  • Non-adherence Rate of Physician to the Recommended Dosing Regimen [ Time Frame: Approximately 16 months ]
  • Percentage of Participants on Tocilizumab Monotherapy at Study Entry [ Time Frame: At baseline ]
  • Total Tender Joint Count (TJC) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
  • Total Swollen Joint Count (SJC) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
  • Disease Activity Score Based on 28 Joints (DAS28) [ Time Frame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks ]
    The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad. The Score is developed under the follow formula: DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score. This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Original Secondary Outcome Measures
 (submitted: December 3, 2012)
  • Rates of dose modifications/interruptions [ Time Frame: approximately 14 months ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 14 months ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 14 months ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 14 months ]
  • Time to DMARD/steroid dose reduction/withdrawal [ Time Frame: approximately 14 months ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 14 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis
Official Title A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Brief Summary This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with rheumatoid arthritis (RA) initiated on treatment with tocilizumab
Condition Rheumatoid Arthritis
Intervention Biological: Tocilizumab
Tocilizumab was administered according to the local label.
Other Name: Actemra
Study Groups/Cohorts Tocilizumab
Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).
Intervention: Biological: Tocilizumab
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 Completed
Actual Enrollment
 (submitted: October 17, 2013)
16
Original Estimated Enrollment
 (submitted: December 3, 2012)
25
Actual Study Completion Date March 6, 2014
Actual Primary Completion Date March 6, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
  • Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit

Exclusion Criteria:

  • Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
  • Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT01741688
Other Study ID Numbers ML28206
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2017