CR6086-2-02
Research type
Research Study
Full title
A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis
IRAS ID
230804
Contact name
Peter Taylor
Contact email
Sponsor organisation
Rottapharm Biotech S.r.l.
Eudract number
2016-004834-11
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Rheumatoid Arthritis (RA) is an autoimmune disease, an illness that occurs when the body tissues are attacked by its own immune system, mainly affecting joints such as the knees, wrists, knuckles and middle joints of the fingers, but also affecting other organ systems. The main symptoms of RA are pain, tenderness, swelling and limited motion of the affected joints. The most important factor for a good prognosis for patients with rheumatoid arthritis is to receive adequate treatment in the early stage of the disease. Patients who receive treatment at an early stage of the disease are more likely to have a favourable course of the disease in the long term.
The current standard treatment for rheumatoid arthritis consists of DMARDs (Disease-modifying antirheumatic drugs), such as methotrexate (MTX), sometimes in combination with other non-biological drugs, as a first choice. As an alternative, MTX can be combined with biological drugs (obtained from a material of biological origin such as living cells or tissue), an approach more likely to be used in treatment of later, or more severe RA.
The drug tested in this study, CR6086, is a non-biological drug with a novel mode of action. It is expected to decrease inflammation as well as to regulate the imbalances in the immune system associated with RA. The aim of the trial is to prove that CR6086 combined with methotrexate (the current standard medication) is more effective than methotrexate monotherapy in patients with early RA and to study CR6086 safety and pharmacokinetics (how fast the study drug is taken up, metabolized and eliminated from the body).REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0295
Date of REC Opinion
20 Oct 2017
REC opinion
Further Information Favourable Opinion