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

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

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: 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

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: Tocilizumab

Layout table for study information
Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Actual Study Start Date : October 26, 2012
Actual Primary Completion Date : March 6, 2014
Actual Study Completion Date : March 6, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Group/Cohort Intervention/treatment
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).
Biological: Tocilizumab
Tocilizumab was administered according to the local label.
Other Name: Actemra




Primary Outcome Measures :
  1. Number of Participants on Tocilizumab at 6 Months After Treatment Initiation [ Time Frame: At 6 months ]

Secondary Outcome Measures :
  1. Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis [ Time Frame: At baseline ]
    Systemic manifestation measured by C-reactive protein levels > 3

  2. 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.

  3. Number of Participants Starting Tocilizumab After Failing Other Biologic Agents [ Time Frame: At baseline ]
    Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.

  4. Median Dose at 6 Months [ Time Frame: At 6 months ]
  5. Number of Participants With Dose Modifications at 6 Months [ Time Frame: At 6 months ]
  6. Median Duration of Treatment [ Time Frame: Approximately 16 months ]
  7. 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.

  8. 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.

  9. 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.

  10. Time to Restoration of Initial Dosing Regimen [ Time Frame: Approximately 16 months ]
  11. Non-adherence Rate of Physician to the Recommended Dosing Regimen [ Time Frame: Approximately 16 months ]
  12. Percentage of Participants on Tocilizumab Monotherapy at Study Entry [ Time Frame: At baseline ]
  13. 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 ]
  14. 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 ]
  15. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with rheumatoid arthritis (RA) initiated on treatment with tocilizumab
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

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 ClinicalTrials.gov identifier (NCT number): NCT01741688


Locations
Layout table for location information
Peru
ABK Reuma SRL- Medicentro BioCiencias
Lima, Peru, Lima 21
Hospital de la Mujer
Lima, Peru, Lima 34
Clinica San Borja; Servicio De Reumatologia
Lima, Peru, Lima 41
Clinica El Golf
San Isidro, Peru, L27 Lima
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01741688    
Other Study ID Numbers: ML28206
First Posted: December 5, 2012    Key Record Dates
Results First Posted: October 12, 2015
Last Update Posted: August 1, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases