Trial Search Results
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
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 with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study.
Stanford is currently accepting patients for this trial.
Collaborator: Iqvia Pty Ltd
- Biological: GSK3196165
- Drug: csDMARD(s)
- 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
- 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
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
- 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).
- 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
- 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
- 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
- Pregnant or lactating, or women planning to become pregnant or initiating
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study