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

NCT05165771 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: GS-US-561-58982021-002664-52
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28\[CRP\]) at Week 12.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Score (DAS) Based on 28 Joints Using C-reactive Protein (CRP) DAS28 (CRP) at Week 12

  The DAS28(CRP) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), subject's global assessment (SGA) of disease activity assessed using visual analog scale (VAS) on a scale of 0-100 (0 indicating no arthritis and 100 indicating extremely active arthritis), and high-sensitivity C-reactive protein (hsCRP) measurement for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

  Baseline, Week 12

Secondary Outcomes (16)

• Percentage of Participants Who Achieve American College of Rheumatology 20% Improvement (ACR20) Response at Week 12

  Week 12

• Percentage of Participants Who Achieve ACR 50% Improvement (ACR50) Response at Week 12

  Week 12

• Percentage of Participants Who Achieve ACR 70% Improvement (ACR70) Response at Week 12

  Week 12

• Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12

  Baseline, Week 12

• Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12

  Baseline, Week 12

Study Arms (4)

GS-5718 Dose A

EXPERIMENTAL

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.

Drug: GS-5718; Drug: Placebo to match GS-5718; Drug: Placebo to match Tofacitinib

GS-5718 Dose B

EXPERIMENTAL

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.

Drug: GS-5718; Drug: Placebo to match GS-5718; Drug: Placebo to match Tofacitinib

Tofacitinib

ACTIVE COMPARATOR

Participants will receive tofacitinib 5 mg twice daily + PTM GS-5718 (Dose A + Dose B) once daily for up to 12 weeks.

Drug: Placebo to match GS-5718; Drug: Tofacitinib 5 mg

Placebo

PLACEBO COMPARATOR

Participants will receive PTM GS-5718 (Dose A + Dose B) once daily + PTM tofacitinib twice daily for up to 12 weeks.

Drug: Placebo to match GS-5718; Drug: Placebo to match Tofacitinib

Interventions

GS-5718 DRUG

Tablets administered orally

GS-5718 Dose A

Placebo to match GS-5718 DRUG

Tablets administered orally

GS-5718 Dose A; GS-5718 Dose B; Placebo; Tofacitinib

Tofacitinib 5 mg DRUG

Tablets administered orally

Also known as: XELJANZ®

Tofacitinib

Placebo to match Tofacitinib DRUG

Tablets administered orally

GS-5718 Dose A; GS-5718 Dose B; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
• 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.

You may not qualify if:

• Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
• Prior exposure to any Janus kinase inhibitor

Sponsors & Collaborators

• Gilead Sciences: lead

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: July 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share