Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

Phase 1

• Conditions: Moderately to Severely Active Rheumatoid Arthritis; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-005307-83-HU
• Lead Sponsor: R-Pharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-28
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1575

Inclusion Criteria

1. Male or female subjects =18 years of age
2. Subjects willing and able to sign informed consent
3. 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. 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.
4. Inadequate response to treatment with oral, SC, or intramuscular (IM) MTX (as defined by protocol) 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.
5. Subjects must have moderately to severely active RA disease as defined by all of the following:
a. =6 tender joints (68-joint count) at Screening and baseline; and
b. =6 swollen joints (66-joint count) at Screening and baseline; and
c. CRP above ULN at Screening based on the central laboratory results
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1345
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 230

Exclusion Criteria

1. 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
2. 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)
3. Prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R (including Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
4. Treatment with any cell-depleting therapies including anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, and anti-CD19)
5. Past history of exposure to TNFi therapy
6. Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to
baseline
7. Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
8. Prior history of no response to hydroxychloroquine and sulfasalazine
9. Prior use of DMARDs other than MTX is allowed with the following washout periods to be completed prior to baseline:
a. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine,
chloroquine, gold, penicillamine, minocycline, or doxycycline
b. 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 a day for at least 24 hours
c. 24 weeks for cyclophosphamide
10. Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study

Please refer to the Protocol for the full list of exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified