CL04041023 - Clinical Rheumatoid Arthritis Development for Olokizumab
Research type
Research Study
Full title
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy
IRAS ID
205661
Contact name
Hasan Tahir
Contact email
Sponsor organisation
R-Pharm
Eudract number
2015-005307-83
Duration of Study in the UK
2 years, 2 months, days
Research summary
This is a randomised, double-blind, parallel-group, placebo- and active-controlled, multicenter Phase III study that will evaluate the efficacy and safety of Olokizumab (OKZ) in participants with moderately to severely active RA inadequately controlled by Methotrexate (MTX) therapy.
Inadequate response to MTX therapy is defined as a subject with at least 12 weeks of exposure prior to Screening and is classified as either: Primary failure (the absence of any documented clinically significant response); or Secondary failure (documented initial clinical response with subsequent loss of that response or partial response).
The term “inadequately controlled by MTX”/ “Inadequate response to MTX therapy” is in fact the definition of “failing on MTX.
This study will be conducted at approximately 235 global sites across Russia, the US, the EU, Asia, and Latin America. A total of 1575 participants will be randomised. Participants will be assessed for eligibility to enter the study during a 4-week Screening Period.
The four study treatment groups will receive the study medication as follows:
Group 1: Study drug once every 4 weeks, alternated with placebo once every 4 weeks + MTX (injection of the study medication once every 2 weeks; however, the study drug and placebo will be alternated)
Group 2: Study drug once every 2 weeks + MTX
Group 3: Adalimumab once every 2 weeks + MTX
Group 4: Placebo once every 2 weeks + MTX
The study will consist of a 24-week double-blind Treatment Period with the last dose of study drug (OKZ, adalimumab, or placebo) administered at Week 22 in all groups. After completion of the double-blind Treatment Period, participants will be offered the opportunity to enter the long-term OLE (open-label extension) study. Participants who do not consent to participate in the OLE study will come to the End of Treatment Visit 2 weeks after the last dose of the study drug for scheduled assessments. After the EOT Visit, these participants will be scheduled for Safety Follow-Up Visit to perform adequate safety assessments. For participants not entering the OLE, the total amount of time to complete the study will be approximately 48 weeks (inclusive of the Screening, Treatment, and Follow-Up Periods).
Participants who discontinue the randomised treatment prematurely will be required to come to the EOT Visit 2 weeks after the last dose of the study drug (OKZ, adalimumab, or placebo) for scheduled assessments. These participants will subsequently be followed for an additional 20 weeks during a safety Follow-Up Period.
In addition, all participants who withdraw from treatment during the double-blind phase (prior to Week 24) will be required to adhere to the visit schedule outlined in Table 1 of the protocol, as though they were still receiving study treatment.REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0442
Date of REC Opinion
4 Oct 2016
REC opinion
Further Information Unfavourable Opinion