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 not accepting patients for this trial.

Lead Sponsor:

GlaxoSmithKline

Collaborator: Iqvia Pty Ltd

Stanford Investigator(s):

Intervention(s):

  • Biological: GSK3196165
  • Drug: csDMARD(s)

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting