Clinical trial NCT01770834: A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official title: A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs

Brief summary: This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 21 years of age
* Moderate to severe active rheumatoid arthritis (DAS28 \>/= 3.2)
* Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
* Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

* Pregnant or lactating women
* Contra-indication to RoActemra/Actemra treatment according to the local labelling
* Previous treatment with tocilizumab
* 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
* Women of childbearing potential not using effective methods of contraception as defined by protocol

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 years
Secondary outcomes:
measure: Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)
timeFrame: approximately 3 years
measure: Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
timeFrame: approximately 3 years
measure: Treatment regimens: Concomitant medications
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Safat
country: Kuwait
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Jbeil
country: Lebanon
city: Saida
country: Lebanon
city: Tripoli
country: Lebanon
city: Doha
country: Qatar
city: Dubai
country: United Arab Emirates
city: Dubai
country: United Arab Emirates
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: