A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
- Registration Number
- NCT01670045
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rheumatoid Arthritis Participants 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 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation Month 6
- Secondary Outcome Measures
Name Time Method Number of Participants With Different Types of Simplified Disease Activity Index (SDAI) Baseline up to Month 6 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.
Percentage of Participants With Tocilizumab Dose Modifications Baseline up to Month 6 Percentage of Participants With RA Diagnosis Baseline up to Day 5 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 Rheumatoid Factor Status Baseline up to Day 5 Percentage of participants with rheumatoid factor status was reported as "positive" or "negative".
Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria Baseline up to Month 6 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 Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids Baseline, up to Month 6 Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.
Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline Baseline, Month 1, 2, 3, 4, 5, 6 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.
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 Baseline, Months 3, 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.
Percentage of Participants With Different Body Mass Index (BMI) Baseline up to Day 5 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 Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status Baseline up to Day 5 Percentage of participants with anti-CCP status were reported as "positive", negative" and "unknown".
Number of Participants With Different Types of Clinical Disease Activity Index (CDAI) Baseline up to Month 6 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 Month 1, 2, 3, 4, 5, 6 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 \[either C-reactive protein or erythrocyte sedimentation rate\].