Clinical trial NCT01649817: A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)
Official title: Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients suitable for treatment with RoActemra/Actemra according to SPC

Brief summary: This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
* RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
* Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Participation in interventional clinical trials during the observational period

Primary outcomes:
measure: Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment
timeFrame: 12 months
Secondary outcomes:
measure: Frequency of withdrawal (according to reasons)
timeFrame: 12 months
measure: Frequency of dose modifications
timeFrame: 12 months
measure: Change in disease activity (DAS28)
timeFrame: from baseline to Month 6 or withdrawal, whichever comes first
Other outcomes:
Locations:
city: Agia Paraskevi
country: Greece
city: Agios Dimitrios
country: Greece
city: Argiroupoli
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Chalandri
country: Greece
city: Chania
country: Greece
city: Eleusina
country: Greece
city: Herakleio
country: Greece
city: Ioannina
country: Greece
city: Kifisia
country: Greece
city: Korinthos
country: Greece
city: Peristeri
country: Greece
city: Peuki
country: Greece
city: Rethymno
country: Greece
city: Serres
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Volos
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: