Impact of RA characteristics on outcome of study drug dose tapering
Research type
Research Study
Full title
A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)
IRAS ID
163225
Contact name
Paul Emery
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2014-001114-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
Rheumatoid arthritis (RA) is a chronic progressive disabling disease affecting mainly the joints and approximately 1% of the population. TNFi (tumor necrosis factor inhibitor) therapies have demonstrated their effectiveness in RA with improvement of disease course and prevention of joint damage progression. Humira® (adalimumab) dosed every other week (eow) is approved in the UK and other countries for RA treatment.
For patients treated with TNFi, including Humira®, who achieve clinical remission (status of absence or very few RA symptoms), international recommendations propose the option of tapering i.e. reducing the dose of TNFi. However, it’s not yet known how to predict whose patients remain on target and who is at risk of worsening their RA (flare) upon tapering.
This is a Phase IV, randomized, double-blinded trial; it will investigate the association between patients’ residual inflammation as detected by imaging and other disease characteristics, and the risk of RA flare after reducing or withdrawing adalimumab. Furthermore the effectiveness of retreatment in case of flares will be examined. This Study will help physicians to better understand which patients can be chosen for tapering.
Patients in RA clinical remission for at least 6 months and on adalimumab eow for at least 12 months after 4 weeks maintaining treatments will be randomly assigned to receive a reduced dosing frequency (to every 3 weeks) of either adalimumab (83%) or placebo (inactive substance that looks like adalimumab) (17%) during 36 weeks. At any time all patients who flare will enter an open-label rescue arm with adalimumab normal dosing of eow.
The study will be conducted in the EU (including the UK), Canada and Australia and can last up to 56 weeks. At study completion, patients can go back to regular standard of care. Patients will have the option to participate in additional biomarker and genetic studies.REC name
North East - York Research Ethics Committee
REC reference
14/NE/1169
Date of REC Opinion
25 Nov 2014
REC opinion
Further Information Favourable Opinion