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.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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.

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 open-label extension (OLE) study in the Investigator's judgement. 2. Subject has evidence of active tuberculosis (TB) 3. Subject has planned surgery during the first 12 weeks of the OLE. 4. 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. 5. 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. 6. Subject is unwilling or unable to follow the procedures outlined in the protocol. 7. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03120949
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	R-Pharm
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mikhail Samsonov
Principal Investigator Affiliation	Chief Medical Officer, R-Pharm
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Argentina, Brazil, Bulgaria, Colombia, Czechia, Estonia, Germany, Hungary, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment Arm 1

Olokizumab 64 mg SC q4w + Methotrexate (oral)

Experimental: Treatment Arm 2

Olokizumab 64 mg SC q2w + Methotrexate (oral)

Interventions

Drug: - Olokizumab 64 mg SC q4w

Treatment Arm 1, Experimental, Olokizumab 64 mg Subcutaneous q4w + Methotrexate (oral)

Drug: - Olokizumab 64 mg SC q2w

Treatment Arm 2, Experimental, Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)

Drug: - Methotrexate

Treatment Arm 1, Experimental, Olokizumab 64 mg Subcutaneous q4w + Methotrexate (oral); Treatment Arm 2, Experimental, Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsville, Alabama

Status

Withdrawn

Address

Rheumatology Associates Of North Alabama- RANA PC

Huntsville, Alabama, 35801

Glendale, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, 85306

Site Contact

Ramina Jajoo

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