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

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra

Description

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
• Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

• Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
• Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
• Patients 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 RoActemra/Actemra
• Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With RA Diagnosis	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".	Baseline up to Day 5
Percentage of Participants With Different Body Mass Index (BMI)	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.	Baseline up to Day 5
Percentage of Participants With Rheumatoid Factor Status	Percentage of participants with rheumatoid factor status was reported as "positive" or "negative".	Baseline up to Day 5
Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status	Percentage of participants with anti-CCP status were reported as "positive", negative" and "unknown".	Baseline up to Day 5
Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline	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.	Baseline, Month 1, 2, 3, 4, 5, 6
Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria	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.	Baseline up to Month 6
Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)	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.	Baseline up to Month 6
Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)	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.	Baseline up to Month 6
Percentage of Participants Achieving a Response According to ACR Criteria	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].	Month 1, 2, 3, 4, 5, 6
Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids	Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.	Baseline, up to Month 6
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6	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.	Baseline, Months 3, 6
Percentage of Participants With Tocilizumab Dose Modifications		Baseline up to Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): June 1, 2014

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (ESTIMATE): August 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 24, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28216