Phase 2 study of RO7123520 as adjunct therapy for Rheumatoid Arthritis
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-α inhibitors
IRAS ID
217456
Contact name
Andrew Filer
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2016-002126-36
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Existing treatments for rheumatoid arthritis (RA) target the white cells that are involved in both inflammation and fighting infection. RO7123520 is a new drug of the type called anti-cadherin-11 monoclonal antibody. RO7123520 is different because it targets the cells in the joint (fibroblasts) that become persistently activated in RA and cause damage to joint structures. These cells do not play a part in fighting infection. The drug may therefore offer a new approach to treating RA that does not suppress the immune system as the current standard treatments do. Therefore, it can be used in addition to current treatments to enhance the response.
The principal aim of this randomised, double-blind, placebo controlled study is to establish the safety, tolerability and efficacy of RO7123520 when administered to patients with RA who have not responded well to their current treatments. RO7123520 or placebo will be given in addition to the standard treatment. The study consists of 3 parts. Part 1 is to establish the safety of RO7123520 in RA patients. If the drug is deemed well tolerated the study will proceed to Part 2 to study the efficacy. If Part 2 is successful, Part 3 will be initiated to evaluate different doses of RO7123520 for safety and efficacy. The study will enrol 9 patients in Part 1, 90 patients in Part 2 and 105 or150 patients in Part 3. Participants will receive 4 doses of RO7123520. There will also be the option to enrol in an extension study and receive 3 additional doses of RO7123520. The duration of the main study with screening is 20 weeks, and 32 weeks with the extension period.
Study assessments include physical examinations, vital signs, ECG, blood and urine tests, optional synovial fluid and tissue biopsies, questionnaires, DEXA and MRI scans.
The study will run at approximately 85 sites worldwide with 8 UK sites. The study is sponsored by F. Hoffmann-La Roche Ltd.REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0038
Date of REC Opinion
7 Apr 2017
REC opinion
Further Information Favourable Opinion