ong term extension study to assess Efficacy and safety of GSK3196165 in the treatment of rheumatoid arthritis
- Conditions
- Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2020/12/029972
- Lead Sponsor
- GlaxoSmithKline Research Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. 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.
2. Body weight equal to or more than 40 kg
3. Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria
4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
5. For participants on 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).
1. Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent 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 WHO or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
2. 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
o 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 recommencing study treatment and agree to complete the remainder of anti- TB treatment while in the study
OR
o Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specialising in TB on entry to a qualifying study.
3. Current or previous active Mycobacterium tuberculosis (TB) regardless of treatment.
4. 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 patientâ??s participation.
5. 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.
6. 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.
7. 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 patientâ??s participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the long-term safety of GSK3196165 at weekly doses of 90 mg or 150 mg for the treatment of participants with moderately to severely active rheumatoid arthritis (RA).Timepoint: - Incidence of adverse events and serious adverse events and adverse events of special interests. <br/ ><br>- Change from baseline in key laboratory parameters. <br/ ><br>- Proportion of participants with NCI-CTCAE more than equal to Grade 3 haematological and or clinical chemistry abnormalities. <br/ ><br>(Time point- Entire duration of trial)
- Secondary Outcome Measures
Name Time Method To determine effects of GSK3196165 on Patient Reported Outcomes (PROs)Timepoint: Absolute values at Weeks 24, 48 and every 48 <br/ ><br>weeks;To determine the immunogenic potential of GSK3196165.Timepoint: Anti-GSK3196165 antibodies;To determine the long-term efficacy of GSK3196165.Timepoint: Proportion of participants at Weeks 24, 48 and every 48 weeks <br/ ><br>