Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment
NCT ID: NCT05165771
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2022-07-31
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis
NCT02176876
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
NCT02885181
Study of GS-0272 in Participants With Rheumatoid Arthritis
NCT06031415
Study of GS-0151 in Participants With Rheumatoid Arthritis
NCT06902519
Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis
NCT05572567
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GS-5718 Dose A
Participants will receive GS-5718 Dose A once daily + placebo to match (PTM) GS-5718 Dose B once daily + PTM tofacitinib twice daily for up to 12 weeks.
GS-5718
Tablets administered orally
Placebo to match GS-5718
Tablets administered orally
Placebo to match Tofacitinib
Tablets administered orally
GS-5718 Dose B
Participants will receive GS-5718 Dose B once daily + PTM GS-5718 Dose A once daily + PTM tofacitinib twice daily for up to 12 weeks.
GS-5718
Tablets administered orally
Placebo to match GS-5718
Tablets administered orally
Placebo to match Tofacitinib
Tablets administered orally
Tofacitinib
Participants will receive tofacitinib 5 mg twice daily + PTM GS-5718 (Dose A + Dose B) once daily for up to 12 weeks.
Placebo to match GS-5718
Tablets administered orally
Tofacitinib 5 mg
Tablets administered orally
Placebo
Participants will receive PTM GS-5718 (Dose A + Dose B) once daily + PTM tofacitinib twice daily for up to 12 weeks.
Placebo to match GS-5718
Tablets administered orally
Placebo to match Tofacitinib
Tablets administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GS-5718
Tablets administered orally
GS-5718
Tablets administered orally
Placebo to match GS-5718
Tablets administered orally
Tofacitinib 5 mg
Tablets administered orally
Placebo to match Tofacitinib
Tablets administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity
* Individual fulfills all of the following minimum disease activity criteria:
* ≥ 6 swollen joints (from a swollen joint count based on 66 joints \[SJC66\]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints \[SJC28\]) at screening and Day 1, and
* ≥ 6 tender joints (from a tender joint count based on 68 joints \[TJC68\]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints \[TJC28\]) at screening and Day 1, and
* hsCRP \> upper limit of normal at screening
* Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.
Exclusion Criteria
* Prior exposure to any Janus kinase inhibitor
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-002664-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-561-5898
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.