Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 83 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Eligibility criteria

Study arms

• Experimental
  GS-9876 - 30 mg

  GS-9876 30 mg + filgotinib placebo for 12 weeks

  Drug: GS-9876 · Drug: Filgotinib placebo · Drug: Methotrexate

• Experimental
  GS-9876 - 10 mg

  GS-9876 10 mg + filgotinib placebo for 12 weeks

  Drug: GS-9876 · Drug: Filgotinib placebo · Drug: Methotrexate

• Experimental
  Filgotinib

  Filgotinib + GS-9876 placebo for 12 weeks

  Drug: Filgotinib · Drug: GS-9876 placebo · Drug: Methotrexate

• Placebo comparator
  Placebo

  GS-9876 placebo + filgotinib placebo for 12 weeks

  Drug: GS-9876 placebo · Drug: Filgotinib placebo · Drug: Methotrexate

Interventions

• DrugGS-9876

  One tablet administered orally once daily

• DrugFilgotinib

  Two tablets administered orally once daily

• DrugGS-9876 placebo

  One tablet administered orally once daily

• DrugFilgotinib placebo

  Two tablets administered orally once daily

• DrugMethotrexate

  Background therapy with methotrexate administered orally or parenterally once weekly

Primary outcomes

1. Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12

   Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

   Time frame: Baseline; Week 12

Secondary outcomes

1. Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12

   American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP).

   Time frame: Week 12

2. Percentage of Participants Who Achieved ACR50 Improvement at Week 12

   ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.

   Time frame: Week 12

3. Percentage of Participants Who Achieved ACR70 Improvement at Week 12

   ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.

   Time frame: Week 12

4. Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

   The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.

   Time frame: Baseline; Week 12

Baseline characteristics

Study documents

• Study protocol · Apr 8, 2016
• Study protocol · Jun 27, 2016
• Study protocol · Jul 11, 2016
• Statistical analysis plan · Oct 26, 2017

Documents are hosted by the registry — open the source record to download them.