Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.
The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.
- Rheumatoid Arthritis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
Subjects may be enrolled in the study only if they meet all of the following 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 additional 12 weeks
4. Subjects must be willing to take folic acid or equivalent throughout the study.
- 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 open-label extension (OLE) study in the Investigator's judgement.
- Subject has evidence of active tuberculosis (TB)
- Subject has planned surgery during the first 12 weeks of the OLE
- Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug
- 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.
- Subject is unwilling or unable to follow the procedures outlined in the protocol
- Other medical or psychiatric conditions, or lab abnormalities that may increase the potential risk associated with study participation and administration of investigational medicinal products (IMPs), or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible
The following restrictions may affect a subject's ability to participate in this study:
- Availability to attend visits according to the protocol within the allowed window period
- Ability to perform self-administration of study drug and availability of caregiver to administer study drug
- Concomitant medication restrictions as described in the Informed Consent Form and protocol (water and concomitant medications are permitted) for at least 9 hours prior to all study visits 8. 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:
1. 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);
2. The subject starts prophylaxis for LTBI according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (see Appendix 4 [Section 13.4]) (treatment with isoniazid for 6 months is not an appropriate
The Investigator (or designee) should review these restrictions with the subject during the Screening Period to determine any potential challenges in the subject's ability to comply with the protocol. Subjects not able to comply with the above mentioned restrictions should not be enrolled into the study.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Treatment Arm 1
|Olokizumab 64 mg SC q4w + Methotrexate (oral)||
Treatment Arm 2
|Olokizumab 64 mg SC q2w + Methotrexate (oral)||
The goal of this Phase III study is to evaluate the long-term safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who previously completed 24 weeks of double-blind treatment with OKZ in the core studies. OKZ is expected to reduce the disease activity and induce an improvement in physical function. The study is expected to provide long-term safety information in a large group of subjects treated with OKZ for up to 106 weeks.