CONTROL
Research type
Research Study
Full title
A Phase 4 open-label randomized controlled study COmparing the effectiveness of adalimumab iNTROduction and methotrexate dose escaLation in subjects with Psoriatic Arthritis (CONTROL)
IRAS ID
210762
Contact name
William Tillett
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-000191-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 7 days
Research summary
Psoriatic Arthritis (PsA) is a type of arthritis which develops in some people with the skin condition psoriasis. It is caused by the body’s immune system mistakenly attacking healthy joint tissue causing inflammation, pain and swelling. Conventional disease modifying anti-rheumatic drugs (csDMARDS) are usually the first treatment given to patients, but even high doses may not effectively reduce signs and symptoms of PsA. Biologic disease modifying anti-rheumatic drugs (bDMARDS) are currently given when patients fail to respond to csDMARDS. They have been shown to significantly improve symptoms of PsA and slow down the structural damage in the joints seen on x-rays.
There is currently a lack of knowledge on how soon after the PsA diagnosis, bDMARDS should be started, and whether bDMARDs should best be combined with csDMARDs. This study is to compare the effect of two PsA treatments: early introduction of adalimumab (bDMARD) combined with low dose of methotrexate (csDMARD) compared to high dose of methotrexate alone. Approximately 240 patients will take part worldwide.
The study consists of 2 parts and in total lasts 32 weeks. In part 1 patients will be randomly assigned to receive either adalimumab 40 mg every other week plus methotrexate 15 mg every week or methotrexate starting at 15 mg and increasing to 20-25 mg (or the highest tolerable dose) every week. After 16 weeks, patients will be assigned to one of four treatment groups based on their response to treatment so far and be treated for a further 16 weeks. At week 24, treatment can be adjusted based on response to therapy by adding, removing, or changing the dose of adalimumab or methotrexate. At week 32 patients will end the trial and return to standard of care therapy.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0615
Date of REC Opinion
26 Jan 2017
REC opinion
Further Information Favourable Opinion