Rheumatoid ArthritisPhase 2NCT02885181
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
A Phase 2 study testing GS-9876, Filgotinib and Methotrexate in people with Rheumatoid Arthritis, run by Gilead Sciences at 19 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GS-9876, Filgotinib and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 21 Sep 2016to 20 Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1
- Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks
- No evidence of active or latent tuberculosis
Who cannot join
- Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
- Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
- Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
- Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
United States9 sites
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, 87102
Medical Associates of North Georgia
Canton, Georgia, 30114
Omega Research Consultants
DeBary, Florida, 32713
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center For Arthritis and Osteoporosis
Elizabethtown, Kentucky, 42701
Accurate Clinical Management - Najam
Houston, Texas, 77084
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
Accurate Clinical Research Inc.
Stafford, Texas, 77477
Medical Center Research LLC
Webster, Texas, 77598
Bulgaria3 sites
MHAT-Plovdiv AD
Plovdiv, 4000
Umhat Kaspela
Plovdiv, 4003
NMTH Tsar Boris III
Sofia, 1233
Czechia2 sites
A-Shine s.r.o.
Pilsen, 31200
Medical Plus, S.R.O.
Uherské Hradiště, 68601
Ukraine2 sites
Kharkiv City Hospital 8
Kharkiv, 140176
Medical Center_Clinic of International Institute of clinical Studies
Kyiv, 2068
Moldova1 site
ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
Chisinau, MD-2025
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GS-9876, Filgotinib, GS-9876 placebo, Filgotinib placebo, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9876Drug
One tablet administered orally once daily
FilgotinibDrug
Two tablets administered orally once daily
GS-9876 placeboDrug
One tablet administered orally once daily
Filgotinib placeboDrug
Two tablets administered orally once daily
MethotrexateDrug
Background therapy with methotrexate administered orally or parenterally once weekly
| Study group | Role | What they receive |
|---|---|---|
| GS-9876 - 30 mg | Experimental | GS-9876 30 mg + filgotinib placebo for 12 weeks Receives: Drug: GS-9876; Drug: Filgotinib placebo; Drug: Methotrexate |
| GS-9876 - 10 mg | Experimental | GS-9876 10 mg + filgotinib placebo for 12 weeks Receives: Drug: GS-9876; Drug: Filgotinib placebo; Drug: Methotrexate |
| Filgotinib | Experimental | Filgotinib + GS-9876 placebo for 12 weeks Receives: Drug: Filgotinib; Drug: GS-9876 placebo; Drug: Methotrexate |
| Placebo | Placebo comparator | GS-9876 placebo + filgotinib placebo for 12 weeks Receives: Drug: GS-9876 placebo; Drug: Filgotinib placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 12
Secondary outcomes (4)
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).
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Baseline; Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start21 Sep 2016
- Primary completion22 Aug 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885181
- Sponsor's protocol ID
- GS-US-379-1582
- Other IDs
- 2016-001496-75, 2016
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2016
- Last updated
- 19 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
- ClinicalTrials.gov ID
- NCT02885181
- Acronym / sponsor ID
- GS-US-379-1582
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 19 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GS-9876 - 30 mg | Experimental | Drug: GS-9876, Drug: Filgotinib placebo, Drug: MethotrexateGS-9876 30 mg + filgotinib placebo for 12 weeks |
| GS-9876 - 10 mg | Experimental | Drug: GS-9876, Drug: Filgotinib placebo, Drug: MethotrexateGS-9876 10 mg + filgotinib placebo for 12 weeks |
| Filgotinib | Experimental | Drug: Filgotinib, Drug: GS-9876 placebo, Drug: MethotrexateFilgotinib + GS-9876 placebo for 12 weeks |
| Placebo | Placebo comparator | Drug: GS-9876 placebo, Drug: Filgotinib placebo, Drug: MethotrexateGS-9876 placebo + filgotinib placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1
- Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks
- No evidence of active or latent tuberculosis
Key exclusion criteria (5 listed)
- Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
- Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
- Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
- Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-9876One tablet administered orally once daily | Drug | GS-9876 - 10 mg, GS-9876 - 30 mg |
| FilgotinibTwo tablets administered orally once daily | Drug | Filgotinib |
| GS-9876 placeboOne tablet administered orally once daily | Drug | Filgotinib, Placebo |
| Filgotinib placeboTwo tablets administered orally once daily | Drug | GS-9876 - 10 mg, GS-9876 - 30 mg, Placebo |
| MethotrexateBackground therapy with methotrexate administered orally or parenterally once weekly | Drug | Filgotinib, GS-9876 - 10 mg, GS-9876 - 30 mg, Placebo |
Primary outcome
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
Time frame: Baseline; 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.
4 secondary outcomes
Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved ACR50 Improvement at Week 12
Time frame: Week 12
Percentage of Participants Who Achieved ACR70 Improvement at Week 12
Time frame: Week 12
Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
Time frame: Baseline; Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GS-9876, Filgotinib and Methotrexate in people with Rheumatoid Arthritis, run by Gilead Sciences at 19 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Bulgaria, Czechia, Ukraine, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 (time frame: Baseline; Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.