No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The mean number of flares per patient over 18 months.
Secondary outcome
Mean dose reduction of biological (expressed as percentage of full-dose)
DAS28-CRP over time
Number of patients with any major flare (flare duration >12 weeks)
Functional disability (HAQ) over time
Quality of Life (EQ5D5L) over time
Provider assessed general disease activity (GDA) on a VAS over time
Patient assessed pain on a VAS over time
Flare severity score: OMERACT RA Flare questionnaire over time
Patient Acceptable Symptom State (PASS) over time
Likert transition question over time
(Serious) Adverse Events
Background summary
Biological Disease Modifying Anti Rheumatic Drugs (bDMARDs) are effective in the treatment of rheumatoid arthritis, but they have several sometimes dose-dependent drawbacks. These include the patient’s need for self-injection, increased risk of infection and malignancy, and high costs. Thus, the question arises whether this adequate level of disease control can be maintained with less medication. Recent studies have shown that disease activity guided dose optimisation (DGDO) of bDMARDS, with trial and error dose reduction or even discontinuation in RA, is non-inferior to usual care. Results showed no difference in functional status, quality of life, relevant radiographic progression or adverse events between DGDO and usual care, although long-term effects are not fully clear. DGDO does however inherently increase the risk of short-lived flares, estimates in the DRESS study being 73% vs 27%. This can make doctors and patients hesitant to start the DGDO process. Therefore, the need arises to better predict and prevent flares during tapering.
We previously developed and externally validated a dynamic prediction model to predict the probability of a flare occurring within 3 months. By predicting a flare, tapering may be halted in time to prevent a flare. Our dynamic prediction model performed moderately well with an area under the ROC curve after cross-validation of 0.76 (95% CI 0.69-0.83). Using dynamic predictions added to DGDO to guide tapering reduced the number of flares and retained most of the reduction in bDMARD dose compared to DGDO alone. These promising simulation results should however be confirmed in a controlled study.
Study objective
The number of flares during tapering of biologicals in patient with rheumatoid arthritis can be reduced by using a dynamic flare prediction model
Study design
0,3,6,9,12,15,18 months
Intervention
Dynamic flare prediction model
Inclusion criteria
• A clinical diagnosis of rheumatoid arthritis as assessed by the treating rheumatologist.
It will be registered if patients meet ACR 1987 or EULAR/ACR 2010 criteria. If these criteria are not met, the separate components of the criteria will be registered.
• Treatment of their RA with one of the following bDMARDs that are registered for RA in ≥66% of the standard dose (i.e. maximally one dose reduction step previously taken): adalimumab, certolizumab, golimumab, infliximab, etanercept, sarilumab, tocilizumab or abatacept).
• Patient is eligible to taper bDMARD according to treating physician (i.e. no other indication for bDMARD such as psoriasis or IBD, i.e. no recent relevant radiographic progression).
• Stable low disease activity with current bDMARD for ≥ 6 months according to treating physician
• Current DAS28-CRP ≤ 2.9 (low disease activity)
or
Current stable low disease activity according to treating physician and patient with a maximum DAS28-CRP ≤3.5 (i.e. 2.9 + measurement error in DAS28 (~0.6)(33)).
• Patient is willing to taper (and if possible, stop) his/her bDMARD as well as to continue his/her current bDMARD dose.
• At least 18 years of age
Exclusion criteria
• Recent earlier (<6 months) tapering attempt(s) with the same bDMARD that failed according to treating physician
• Inability to comply with protocol, e.g. no possibility to measure outcome over 18 months, e.g. insufficient knowledge of the Dutch language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9798 |
| CCMO | NL74537.041.21 |
| OMON | NL-OMON56102 |