The purpose of this study is to determine how safe and effective the study drug Olokizumab
is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully
responding to, treatment with methotrexate (MTX).
Drug: Olokizumab q4w
Drug: Olokizumab q2w
Drug: Placebo q2w
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Full eligibility criteria for NCT02760368
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Subjects may be enrolled in the study only if they meet all of the following criteria:
Subjects willing and able to sign informed consent
Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 12 weeks prior to Screening.
Inadequate response to treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if intolerant to higher doses).
The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
Subjects must be willing to take folic acid or equivalent throughout the study
Subjects must have moderately to severely active RA disease as defined by all of the following:
≥6 tender joints (68 joint count) at Screening and baseline; and
≥6 swollen joints (66 joint count) at Screening and baseline; and
CRP above ULN at Screening based on the central laboratory results.
Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus)
Prior exposure to any licensed or investigational compound directly or indirectly targeting IL 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19)
Prior use of bDMARDs, with the following exception:
• Subjects who discontinued TNFi therapy due to a reason other than lack of efficacy are allowed to enter the study (TNFi therapy should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA). The use of TNFi therapy within the following windows prior to baseline is exclusionary: i. 4 weeks for etanercept ii. 8 weeks for infliximab iii. 10 weeks for adalimumab, certolizumab, and golimumab
Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
Prior documented history of no response to hydroxychloroquine and sulfasalazine
Prior use of cDMARDs (other than MTX) within the following windows prior to baseline
(cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):
4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or d oxycycline
12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours
24 weeks for cyclophosphamide
Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
Subjects with HIV infection
Subjects with current active TB infection or a history of active TB infection
History of untreated latent TB infection (LTBI), regardless of IGRA result at Screening
Concurrent malignancy or a history of malignancy within the last 5 years
History of chronic alcohol or drug abuse as judged by the Investigator
Female subjects who are pregnant, currently lactating
Female subjects of childbearing potential who are not willing to use a highly effective method of contraception during the study OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study
Subjects with a known hypersensitivity to any component of the OKZ drug product, or placebo
Other exclusion criteria may apply
All locations for NCT02760368
DCC 'Sv. Pantaleymon' OOD
Pleven, Bulgaria, 5800
UMHAT "Kaspela", EOOD
Plovdiv, Bulgaria, 4002
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria, 1431
MC "Synexus - Sofia", EOOD
Sofia, Bulgaria, 1784
Russian Federation (33)
Regional State Budgetary Healthcare Institution "Barnaul City Hospital #4"
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
Moscow, Russian Federation, 115522
LLC "Tekhnologii Zdoroviya"
Saint Petersburg, Russian Federation, 191144
SBHI "North-West Federat Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, Russian Federation, 197341
View full eligibility
Tris trial is registered with FDA with number: NCT02760368. The sponsor of the trial is R-Pharm and it is looking for 428 volunteers for the current phase.
Official trial title: A Randomized, Double Blind, Parallel Group, Placebo 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
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