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

Hoffmann-La Roche43 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

Tocilizumab in accordance with the licensed label recommendation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Balikpapan, Indonesia

Unnamed facility

Bandung, Indonesia

Unnamed facility

Central Jakarta, Indonesia

Unnamed facility

Central Java, Indonesia

Outcomes

Primary Outcomes

Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation

Time frame: Month 6

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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".

Time frame: 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".

Time frame: 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.

Data from ClinicalTrials.gov

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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.

Time frame: 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 \[either C-reactive protein or erythrocyte sedimentation rate\].

Time frame: Month 1, 2, 3, 4, 5, 6