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Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease (CREDO 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02760368
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : December 3, 2018
Sponsor:
Collaborators:
Quintiles, Inc.
OCT Clinical Trials
Mene Research
Information provided by (Responsible Party):
R-Pharm

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Olokizumab q4w Drug: Olokizumab q2w Drug: Placebo q2w Phase 3

Detailed Description:
The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to MTX. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and improve physical function. The study is expected to provide safety information in a large group of subjects over at least a 24 week period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Olokizumab q4w + Methotrexate
Olokizumab 64 mg Subcutaneous q4w + Methotrexate (oral)
Drug: Olokizumab q4w
Experimental: Arm 2: Olokizumab q2w + Methotrexate
Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)
Drug: Olokizumab q2w
Placebo Comparator: Arm 3: Placebo q2w + Methotrexate
Placebo Subcutaneous q2w + Methotrexate (oral)
Drug: Placebo q2w



Primary Outcome Measures :
  1. ACR20 response [ Time Frame: at Week 12 ]
    The difference between OKZ and placebo in the percentage of subjects achieving an ACR20 response and remaining on randomized treatment and in the study at Week 12.


Secondary Outcome Measures :
  1. Difference between OKZ and placebo in the percentage of subjects achieving low disease activity [ Time Frame: at Week 12 ]
    Defined as DAS28 (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12.

  2. Difference between OKZ and placebo in the improvement of physical ability [ Time Frame: Baseline to Week 12 ]
    As measured by the Health Assessment Questionnaire Disability Index (HAQ DI)

  3. ACR50 response [ Time Frame: at Week 24 ]
    Difference between OKZ and placebo in the percentage of subjects achieving an ACR50 response and remaining on randomized treatment and in the study at Week 24.

  4. Simplified Disease Activity Index (SDAI) ≤3.3 (remission) [ Time Frame: at Week 24 ]
    Difference between OKZ and placebo in the percentage of subjects with (SDAI) ≤3.3 (remission) and remaining on randomized treatment and in the study at Week 24.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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):

    1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or d oxycycline
    2. 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
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760368


Locations
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Bulgaria
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
Regional State Budgetary Healthcare Institution "Barnaul City Hospital #4"
Barnaul, Altai Region, Russian Federation, 656050
Medical Center LLC "Maksimum Zdoroviya"
Kemerovo, Kemerovo Oblast, Russian Federation, 650056
SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
Kemerovo, Kemerovskaya Oblast, Russian Federation, 650000
Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region
Kursk, Kurskaya Oblast, Russian Federation, 305007
SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
Saint Petersburg, Leningradskaya Oblast, Russian Federation, 190068
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital #1 n.a. Pirogov" Healthcare Departament of Moscow
Moscow, Moscovskaya Oblast, Russian Federation, 119094
FSBEI HE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation", UCH #1
Moscow, Moscovskaya Oblast, Russian Federation, 119991
FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction
Moscow, Moscovskaya Oblast, Russian Federation, 119991
SBEI HPE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation" UCH #3
Moscow, Moscovskaya Oblast, Russian Federation, 119991
State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
Moscow, Moscow Region, Russian Federation, 111539
SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"
Moscow, Moskovskaya Oblast, Russian Federation, 115093
SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"
Novosibirsk, Novosibirsk Oblast, Russian Federation, 630099
LLC "Clinical Diagnostic Center "Ultramed"
Omsk, Omskaya Oblast, Russian Federation, 644024
Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"
Omsk, Omskaya Oblast, Russian Federation, 644111
SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
Petrozavodsk, Republic Of Karelia, Russian Federation, 185019
State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"
Ufa, Respublic Of Bashkortostan, Russian Federation, 450005
SBEI HPE "Rostov State Medical University" of Ministry of Health of the Russian Federation
Rostov, Rostovskaya Oblast, Russian Federation, 344022
SBEI HPE "SSMU n.a. V.I. Razumovsky of MoH of RF", Clinical Hospital n.a. S.R. Mirotvorcev, Therapeutic Departament
Saratov, Saratovskaya Oblast, Russian Federation, 410012
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Saratovskaya Oblast, Russian Federation, 410053
Non-governmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"
Smolensk, Smolenskaya Oblast, Russian Federation, 214025
SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
Stavropol', Stavropol Region, Russian Federation, 355017
State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1"
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620102
SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6"
Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620149
State Autonomous Healthcare Institution "Republican Clinical Hospital of Ministry of Health of Tatarstan Republic
Kazan', The Republic Of Tatarstan, Russian Federation, 420064
State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"
Tula, Tulskaya Oblast, Russian Federation, 300053
State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"
Ulyanovsk, Ulyanovskaya Oblast, Russian Federation, 432063
SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament
Vladimir, Vladimirskaya Oblast, Russian Federation
State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"
Yaroslavl', Yaroslavsakaya Oblast, Russian Federation, 150003
SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department
Yaroslavl', Yaroslavskaya Oblast, Russian Federation, 150062
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
Sponsors and Collaborators
R-Pharm
Quintiles, Inc.
OCT Clinical Trials
Mene Research
Investigators
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Study Director: Mikhail Samsonov R-Pharm

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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT02760368     History of Changes
Other Study ID Numbers: CL04041022
2014-004719-36 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Keywords provided by R-Pharm:
moderate Rheumatoid Arthritis
severe Rheumatoid Arthritis
subcutaneous
Olokizumab

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors