To document the long term safety and efficacy of sarilumab added to DMARDs.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety assessment of sarilumab over time.
Secondary outcome
Proportion of patients who achieve ACR20, DAS28 remission and EULAR response
over time;
HAQ-Di results over time;
Background summary
Rheumatoid arthritis (RA) is a chronic, debilitating disease that primarily
affects the synovial membrane of diarthrodial joints.
This study is intended to provide a long term safety database to better
identify potential late onset adverse events associated with the use of
sarilumab given in addition to DMARDs, as well as to asess long term efficacy.
Study objective
To document the long term safety and efficacy of sarilumab added to DMARDs.
Study design
An uncontrolled open label extension study of sarilumab 200 mg q2w; added to
DMARDs for a duration up to 5 years from the first administration, or until
commercially available in each patient's country or until discontinuation of
the project whichever sooner.
Intervention
A single subcutaneous injection of 200 mg sarilumab every two weeks on top of
DMARDs.
Study burden and risks
The most common side effects reported in previous studies with sarilumab:
Infections, laboratory abnormalities, reactions such as redness, itching, pain
at the injection site, headaches, diarrhea, mouth ulcers, allergic reactions.
Kampenringweg 45 E
Gouda 2803 PE
NL
Kampenringweg 45 E
Gouda 2803 PE
NL
Listed location countries
Age
Inclusion criteria
Patient with Rheumatoid Arthritis (RA) who was previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, or SFY13370 study
Exclusion criteria
- Patient with any adverse event leading to permanent study drug discontinuation from a prior study.
- Treatment with any concurrent biologic agents including investigational drugs for the treatment of Rheumatoid Arthritis (RA)
- Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study
Design
Recruitment
Medical products/devices used
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metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-019262-86-NL |
| ClinicalTrials.gov | NCT01146652 |
| CCMO | NL47910.048.14 |