Clinical trial NCT01741688: An Observational Study of Tocilizumab (Actemra) in Participants 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: 2012-12-05
Enrollment: 16
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: Participants with rheumatoid arthritis (RA) initiated on treatment with tocilizumab

Brief summary: This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adults, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
* Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit

Exclusion Criteria:

* Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
* Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Number of Participants on Tocilizumab at 6 Months After Treatment Initiation
timeFrame: At 6 months
Secondary outcomes:
measure: Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis
timeFrame: At baseline
measure: Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure
timeFrame: At baseline
measure: Number of Participants Starting Tocilizumab After Failing Other Biologic Agents
timeFrame: At baseline
measure: Median Dose at 6 Months
timeFrame: At 6 months
measure: Number of Participants With Dose Modifications at 6 Months
timeFrame: At 6 months
measure: Median Duration of Treatment
timeFrame: Approximately 16 months
measure: Percentage of Participants Discontinued From Tocilizumab for Safety
timeFrame: Approximately 16 months
measure: Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy
timeFrame: Approximately 16 months
measure: Number of Participants Discontinued From Tocilizumab for Other Reasons
timeFrame: Approximately 16 months
measure: Time to Restoration of Initial Dosing Regimen
timeFrame: Approximately 16 months
measure: Non-adherence Rate of Physician to the Recommended Dosing Regimen
timeFrame: Approximately 16 months
measure: Percentage of Participants on Tocilizumab Monotherapy at Study Entry
timeFrame: At baseline
measure: Total Tender Joint Count (TJC)
timeFrame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
measure: Total Swollen Joint Count (SJC)
timeFrame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
measure: Disease Activity Score Based on 28 Joints (DAS28)
timeFrame: At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Other outcomes:
Locations:
city: Lima
country: Peru
facility: ABK Reuma SRL- Medicentro BioCiencias
city: Lima
country: Peru
facility: Hospital de la Mujer
city: Lima
country: Peru
facility: Clinica San Borja; Servicio De Reumatologia
city: San Isidro
country: Peru
facility: Clinica El Golf
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: