Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 1880

Inclusion Criteria

1. Subject must be willing and able to sign informed consent
2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or =10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for =12 additional weeks.
4.Subjects must be willing to take folic acid or equivalent throughout the study.
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 1576
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 304

Exclusion Criteria

1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent AEs or SAEs, infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the OLE study in the Investigator’s judgement.
2. Subject has evidence of active TB
3. Subject with a positive or repeated indeterminate interferon-gamma
release assay (IGRA) result at Week 22 of the core study
? Subjects may be enrolled in the OLE study if they fulfill all 3 of the
following criteria prior to the first dose of study treatment:
a. Active TB is ruled out by a certified TB specialist or pulmonologist who
is familiar with diagnosing and treating TB (as acceptable per local
practice);
b. The subject starts prophylaxis for LTBI according to countryspecific/
Centers for Disease Control and Prevention (CDC) guidelines
(treatment with isoniazid for 6 months is not an appropriate prophylactic
regime for this study and it should not be used); and
c. The subject is willing to complete the entire course of recommended
LTBI therapy
4. Subject has planned surgery during the first 12 weeks of the OLE
study
5. Female subjects who are pregnant or lactating, or who are planning to
become pregnant during the study or within 6 months of the last dose of
study treatment
6. Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment
OR
Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study drug treatment.
7. Subject is unwilling or unable to follow the procedures outlined in the protocol
8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of study treatment, or that may affect study results interpretation and, as per Investigator’s judgement, make the subject ineligible.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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