Clinical trial NCT01670045: A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants With RA Diagnosis
timeFrame: Baseline up to Day 5
measure: Percentage of Participants With Different Body Mass Index (BMI)
timeFrame: Baseline up to Day 5
measure: Percentage of Participants With Rheumatoid Factor Status
timeFrame: Baseline up to Day 5
measure: Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status
timeFrame: Baseline up to Day 5
measure: Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline
timeFrame: Baseline, Month 1, 2, 3, 4, 5, 6
measure: Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria
timeFrame: Baseline up to Month 6
measure: Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)
timeFrame: Baseline up to Month 6
measure: Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)
timeFrame: Baseline up to Month 6
measure: Percentage of Participants Achieving a Response According to ACR Criteria
timeFrame: Month 1, 2, 3, 4, 5, 6
measure: Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids
timeFrame: Baseline, up to Month 6
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
timeFrame: Baseline, Months 3, 6
measure: Percentage of Participants With Tocilizumab Dose Modifications
timeFrame: Baseline up to Month 6
Other outcomes:
Locations:
city: Balikpapan
country: Indonesia
city: Bandung
country: Indonesia
city: Central Jakarta
country: Indonesia
city: Central Java
country: Indonesia
city: Denpasar
country: Indonesia
city: Jakarta
country: Indonesia
city: Malang
country: Indonesia
city: Manado
country: Indonesia
city: Medan
country: Indonesia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: