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
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
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"
State Budgetary Insitution of Healthcare "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Russian Federation, 454076
JSC "Family Medicine Center"
Ekaterinburg, Russian Federation, 620043
LLC Сonsulting and Diagnostics Rheumatology Centre ' Zdorovye sustavy'
Novosibirsk, Russian Federation, 630099
SBEI HPE "Saint Petersburg First State Medical University n.a. Acad. I.P. Pavlov" of Ministry of Healhcare of RF
Saint Petersburg, Russian Federation, 197022
Hacettepe University Medical Faculty Hospital, Rheumatology Departament
Ankara, Altindag, Turkey, 06230
Istanbul University, Istanbul Medical Faculty Internal Diseases Department, Rheumatology Discipline
Istanbul, Fatih, Turkey, 34093
Istanbul University, Cerrahpasa Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
Istanbul, Fatih, Turkey, 34098
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
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.