Clinical trial NCT01562327: A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Official title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 50
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: Rheumatoid arthritis participants treated with tocilizumab

Brief summary: This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
timeFrame: 6 months after treatment initiation
Secondary outcomes:
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
timeFrame: Baseline
measure: Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab
timeFrame: Baseline
measure: Percentage of Participants Who Previously Received DMARDs
timeFrame: Baseline
measure: Reason for DMARDs Withdrawal at Baseline
timeFrame: Baseline
measure: Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab
timeFrame: Baseline
measure: Percentage of Participants Who Previously Received Biologic Agents
timeFrame: Baseline
measure: Reason for Biologic Agent Withdrawal at Baseline
timeFrame: Baseline
measure: Reasons for Dose Modifications
timeFrame: approximately 3 years
measure: Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy
timeFrame: Approximately 3 years
measure: Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy
timeFrame: Baseline, Month 6
measure: Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6
timeFrame: Month 3, Month 6
measure: Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6
timeFrame: Month 3, Month 6
measure: Simplified Disease Activity (SDAI) Response Classification
timeFrame: Month 3, Month 6
measure: European League Against Rheumatism (EULAR) Response
timeFrame: Month 3, Month 6
measure: Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
timeFrame: Month 3, Month 6
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma de
country: Argentina
city: Florencio Varela
country: Argentina
city: La Plata
country: Argentina
city: San Juan
country: Argentina
city: San Miguel De Tucuman
country: Argentina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: