Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.

Key facts

Study ID

NCT02760433

Run by

R-Pharm International, LLC

People needed

368

Starts

2017-01-25

Expected to finish

2019-10-01

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 24 weeks prior to Screening.
• (If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data.)
• Treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance 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
• C-reactive protein (CRP) above Upper limit of normal (ULN) at Screening based on the central laboratory results.
• Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with ≥1 licensed TNFi following at least 12 weeks of therapy with that agent. Inadequate response to treatment is classified as either:
• Primary failure: The absence of any documented clinically significant response; or
• Secondary failure: Documented initial response with subsequent loss of that response or partial response

You may not qualify if…

• 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) (However, subjects may have secondary Sjogren's syndrome or hypothyroidism.)
• Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)
• Prior exposure to any licensed or investigational compound directly or indirectly targeting Interleukin (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) with the exception of rituximab, which is allowed if it was discontinued at least 24 weeks prior to baseline (rituximab 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).
• Prior use of bDMARDs, within the following windows prior to baseline (bDMARDs 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 etanercept and anakinra
• 8 weeks for infliximab
• 10 weeks for adalimumab, certolizumab, and golimumab
• 12 weeks for abatacept
• Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
• 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 doxycycline
• 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
• Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
• 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
• Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline
• Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
• Use of non steroidal anti inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
• Previous participation in this study (randomized) or another study of OKZ
• Subjects with concurrent acute or chronic viral Hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen [HBsAg], total hepatitis B core antibody [anti-HBc], or hepatitis C virus antibody [HCV Ab])
• a) subjects who are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible.
• Subjects with HIV infection

Where it is running

• CHI St. Vincent Hot Springs — Hot Springs, Arkansas, United States
• Medvin Clinical Research — Covina, California, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• Saint Jude Heritage Medical Grp — Fullerton, California, United States
• С V Mehta MD Med Corp. — Hemet, California, United States
• Advanced Medical Research, LLC — Lakewood, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Riverside Medical Clinic — Riverside, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Javed Rheumatology Associates — Newark, Delaware, United States
• RASF - Clinical Research Center — Boca Raton, Florida, United States
• Suncoast Research Group LLC — Miami, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Family Clinical Trials, LLC. — Pembroke Pines, Florida, United States
• AdventHealth Medical Group, PA — Tampa, Florida, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• The Arthritis & Diabetes Clinic, Inc. — Monroe, Louisiana, United States
• Klein and Associates, M.D., P.A. — Hagerstown, Maryland, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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