Status:
TERMINATED
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment ...
Eligibility Criteria
Inclusion
- Participants with rheumatoid arthritis who are aged \>=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
- Body weight \>=40 kilograms (kg).
- Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).
Exclusion
- Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
- Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
- Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
- Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
- Current or previous active TB regardless of treatment.
- Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
- A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
- Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
- Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
- Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
- Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
- Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
- Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
- History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2023
Estimated Enrollment :
2916 Patients enrolled
Trial Details
Trial ID
NCT04333147
Start Date
May 12 2020
End Date
February 24 2023
Last Update
February 7 2024
Active Locations (375)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Flagstaff, Arizona, United States, 86001
3
GSK Investigational Site
Gilbert, Arizona, United States, 85297
4
GSK Investigational Site
Glendale, Arizona, United States, 85306