Trial Search Results

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 an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease

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 an existing medication called a tumour necrosis factor alpha inhibitor

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

R-Pharm

Collaborator: Mene Research

Stanford Investigator(s):

Intervention(s):

  • Drug: Olokizumab q4w
  • Drug: Olokizumab q2w
  • Drug: Placebo q2w

Phase:

Phase 3

Eligibility


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 24 weeks prior to Screening.

   - 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 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

      - CRP above 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.

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) 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):

      1. 4 weeks for etanercept and anakinra

      2. 8 weeks for infliximab

      3. 10 weeks for adalimumab, certolizumab, and golimumab

      4. 12 weeks for abatacept

   - Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or
   change in dosage within 2 weeks prior to baseline

   - Prior 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 doxycycline

      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

   - Other treatments for RA (e.g., Prosorba Device/Column) within 6 months 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

   - Abnormal laboratory values

   - Subjects with concurrent acute or chronic viral Hepatitis B or C infection

   - Subjects with HIV infection

   - Subjects with:

      1. Current active TB disease or a history of active TB disease.

      2. Close contact with an individual with active TB within 1.5yrs prior to Screening

      3. History of untreated latent TB infection (LTBI), regardless of IGRA result at
      Screening

      4. Positive interferon-gamma release assay (IGRA) result at Screening. If
      indeterminate, the IGRA can be repeated once during the Screening Period. If
      there is a second indeterminate result, the subject will be excluded.

   - 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 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting