Switching to sarilumab in patients with rehumatoid arthritis responding well to tocilizumab does not lead to a relevant increase in disease activity and is feasible with a persistence of sarilumab >70% at 6 months
ID
Bron
Verkorte titel
Aandoening
Rheumatoid Arthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Increase in DAS28-CRP from baseline to month 6 compared to the pre-specified non-inferiority margin of 0.6
- Proportion of patients persisting with SRL treatment at month 6, compared to a pre-specified minimum persistence of 70% at month 6
Achtergrond van het onderzoek
Rationale:
Sarilumab (SRL) and tocilizumab (TCZ) are two anti-IL6-receptor antibodies registered for the treatment of moderate to severe rheumatoid arthritis (RA) in patients not responding or intolerant to one or more disease modifiying anti-rheumatic drugs (DMARDs). Both drugs are similar in design, safety and efficacy. SRL is administered less frequently than TCZ (biweekly rather than weekly), thus reducing the injection burden on patients. Furthermore, the possibility of switching from TCZ to SRL is beneficial in case of adverse effects, for pharmaco-economic reasons, and in case of drug shortages.
Objective:
To investigate the effects of switching from TCZ to SRL in clinical practice for RA patients with stable well controlled disease under TCZ treatment.
Design:
This is an observational cohort with a follow up duration of 6 months that will be conducted at the department of rheumatology of the Sint Maartenskliniek, a tertiary referral center specialized in rheumatology, orthopedics and rehabilitation. Patients responding well to a stable dose of TCZ will be approached with an offer to (voluntary) switch to SRL in order to reduce injection burden and because of better cost effectiveness as part of standard care. Patients who choose to switch, and who consent to this observational study, will be included in this cohort and followed for 6 months after switching in order to evaluate the effects of switching.
Participants:
60 patients with rheumatoid arthritis responding well to a stable dose of TCZ will be included.
Primary outcome:
Co-primary endpoints are the efficacy of switching to SRL in patients responding well to TCZ (defined by the change in DAS28-CRP from baseline to month 6 compared to the prespecified non-inferiority margin of 0.6), and the persistence of switching to SRL in patients responding well to TCZ (defined by the proportion of patients persisting with SRL treatment at month 6, com-pared to a pre-specified minimum persistence of 70% at month 6).
Doel van het onderzoek
Switching to sarilumab in patients with rehumatoid arthritis responding well to tocilizumab does not lead to a relevant increase in disease activity and is feasible with a persistence of sarilumab >70% at 6 months
Onderzoeksopzet
Baseline, 3 months, 6 months
Onderzoeksproduct en/of interventie
N/A
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR and/or 1987 RA criteria and/or clini-cal diagnosis of treating rheumatologist (18;19)
- Currently treated with either i.v. or s.c. tocilizumab in a dose of (162mg s.c. weekly/per 10 days/per 2 weeks/per 3 weeks or 8 to 4 mg/kg i.v. every 4 to 6 weeks) for at least 6 months
- Stable low disease activity (DAS28-CRP<2.9 or DAS28-CRP<3.5 and clinical judg-ment of low disease activity by treating rheumatologist)
- >16 years of age
- Ability to read and communicate well in Dutch
- Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participa-tion in this study:
- Previous non-response to sarilumab
- Known relevant contraindications for sarilumab such as elevated liver enzymes, low leuko-cyte or platelet counts or active infection, as judged by the treating rheumatologist.
- no ability to measure the study outcome (e.g. due to limited life expectancy or planned relocation)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8174 |
| Ander register | CMO Arnhem-Nijmegen : CMO number: 2019-5828 |