An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01483326
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-31
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-01
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• Adult patients, >18 years of age
• Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

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Exclusion Criteria

• Contra-indications for RoActemra/Actemra

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in disease activity score (DAS 28)	baseline and up to 4 years

Secondary Outcome Measures

Name	Time	Method
Change in concomitant medication (especially tapering of steroids)	baseline and up to 4 years
Safety: Incidence of adverse events	up to 4 years
Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness)	up to 4 years
Change in disability, assessed by Health Assessment Questionnaire (HAQ)	baseline and up to 4 years
Change in dosage schedule (modification/interruption/discontinuation)	baseline and up to 4 years

Trial Locations

Locations (19)

Scheper Ziekenhuis; 🇳🇱 Emmen, Netherlands

Amphia ziekenhuis, locatie langendijk; 🇳🇱 Breda, Netherlands

Medisch Centrum Twente; Rheumatology; 🇳🇱 Enschede, Netherlands

Maasstadziekenhuis; Reumatologie; 🇳🇱 Rotterdam, Netherlands

Jan Van Breemen Instituut; 🇳🇱 Amsterdam, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

Medisch Centrum Leeuwarden; Reumatology; 🇳🇱 Leeuwarden, Netherlands

St. Antonius Ziekenhuis; Pharmacy; 🇳🇱 Nieuwegein, Netherlands

Gelre Ziekenhuis; Reumatology; 🇳🇱 Apeldoorn, Netherlands

Rijnstate Ziekenhuis; Afdeling Reumatologie; 🇳🇱 Arnhem, Netherlands

Deventer ziekenhuis; 🇳🇱 Deventer, Netherlands

Tergooiziekenhuizen, loc. Hilversum; 🇳🇱 Hilversum, Netherlands

Leyenburg Ziekenhuis; Internal Medecine; 🇳🇱 Den Haag, Netherlands

MC groep - locatie Emmeloord; 🇳🇱 Emmeloord, Netherlands

St. Maartenskliniek; 🇳🇱 Nijmegen, Netherlands

Röpcke Zweers ziekenhuis; Reumatologie; 🇳🇱 Hardenberg, Netherlands

Maastricht University Medical Centre; Rheumatology; 🇳🇱 Maastricht, Netherlands

Vlietland Hospital; 🇳🇱 Schiedam, Netherlands

Ziekenhuis Walcheren; Reumatologie; 🇳🇱 Vlissingen, Netherlands