A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01670045
First received: August 17, 2012
Last updated: April 6, 2016
Last verified: April 2016
  Purpose
This multi-center observational study will evaluate the use and efficacy of tocilizumab in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the licensed label will be followed for 6 months.

Condition Intervention
Rheumatoid Arthritis
Drug: Tocilizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With RA Diagnosis [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: No ]
    Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under "unknown".

  • Percentage of Participants With Different Body Mass Index (BMI) [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: No ]
    BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.

  • Percentage of Participants With Rheumatoid Factor Status [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: No ]
    Percentage of participants with rheumatoid factor status was reported as "positive" or "negative".

  • Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: No ]
    Percentage of participants with anti-CCP status were reported as "positive", negative" and "unknown".

  • Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline [ Time Frame: Baseline, Month 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.

  • Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
    Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.

  • Number of Participants With Different Types of Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
    The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score > 3.3 and ≤ 11 is 'low disease activity', score > 11 and ≤ 26 is 'moderate disease activity', score > 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.

  • Number of Participants With Different Types of Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]
    The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score > 2.8 and ≤ 10 is 'low disease activity', score > 10 and ≤ 22 is 'moderate disease activity', score > 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.

  • Percentage of Participants Achieving a Response According to ACR Criteria [ Time Frame: Month 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
    ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].

  • Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids [ Time Frame: Baseline, up to Month 6 ] [ Designated as safety issue: No ]
    Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.

  • Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 [ Time Frame: Baseline, Months 3, 6 ] [ Designated as safety issue: No ]
    Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.

  • Percentage of Participants With Tocilizumab Dose Modifications [ Time Frame: Baseline up to Month 6 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: March 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rheumatoid Arthritis Participants
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 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study will receive tocilizumab in accordance with the licensed label recommendations, and will be observed for 6 months. The study is designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication is required.
Drug: Tocilizumab
Tocilizumab in accordance with the licensed label recommendation.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with rheumatoid arthritis initiating treatment with tocilizumab
Criteria

Inclusion Criteria:

  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Participants in whom the treating physician has made the decision to commence tocilizumab treatment in accordance with the local label (disease-modifying anti-rheumatic drugs-inadequate response [DMARD-IR], tumor necrosis factor [TNF]-IR or need of tocilizumab monotherapy); 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 previously received tocilizumab in a clinical trial or for compassionate use
  • Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
  • Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670045

Locations
Indonesia
Balikpapan, Indonesia, 76121
Bandung, Indonesia, 40161
Central Jakarta, Indonesia, 10430
Central Java, Indonesia
Denpasar, Indonesia
Jakarta, Indonesia
Malang, Indonesia, 65111
Manado, Indonesia, 95115
Medan, Indonesia, 20157
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01670045     History of Changes
Other Study ID Numbers: ML28216 
Study First Received: August 17, 2012
Results First Received: April 6, 2016
Last Updated: April 6, 2016
Health Authority: Indonesia: National Agency for Drug and Food Control (NA-DFC)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2016