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

A Phase 2 study testing GS-5718 and Tofacitinib 5 mg in people with Rheumatoid Arthritis, run by Gilead Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. 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-5718 and Tofacitinib 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jul 2022to Mar 2023
Phase: Phase 2
Are there results?: None posted in the registry

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

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.

Who cannot join

Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
Prior exposure to any Janus kinase inhibitor
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Conditions: Rheumatoid Arthritis
Being tested: GS-5718, Placebo to match GS-5718, Tofacitinib 5 mg, Placebo to match Tofacitinib
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-5718Drug
Tablets administered orally
GS-5718Drug
Tablets administered orally
Placebo to match GS-5718Drug
Tablets administered orally
Tofacitinib 5 mgDrug
Also called XELJANZ®
Tablets administered orally
Placebo to match TofacitinibDrug
Tablets administered orally

Study groups in NCT05165771
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo to match GS-5718; Drug: Placebo to match Tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 12

Secondary outcomes (16)

Percentage of Participants Who Achieve American College of Rheumatology 20% Improvement (ACR20) Response at Week 12
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) assessed using VAS on a scale of 0-100 (0 indicating no disease activity and 100 indicating maximum disease activity) and SGA assessed using VAS on a scale of 0-100 (0 indicating no arthritis and 100 indicating extremely active arthritis); participant's pain assessment using VAS on a scale of 0-100 (0 indicating no pain and 100 indicating severe pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip, and errands/chores and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); hsCRP.
Measured: Week 12
Percentage of Participants Who Achieve ACR 50% Improvement (ACR50) Response at Week 12
ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA assessed using VAS on a scale of 0-100 (0 indicating no disease activity and 100 indicating maximum disease activity) and SGA assessed using VAS on a scale of 0-100 (0 indicating no arthritis and 100 indicating extremely active arthritis); participant's pain assessment using VAS on a scale of 0-100 (0 indicating no pain and 100 indicating severe pain); HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and errands/chores and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); hsCRP.
Measured: Week 12
Percentage of Participants Who Achieve ACR 70% Improvement (ACR70) Response at Week 12
ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA assessed using VAS on a scale of 0-100 (0 indicating no disease activity and 100 indicating maximum disease activity) and SGA assessed using VAS on a scale of 0-100 (0 indicating no arthritis and 100 indicating extremely active arthritis); participant's pain assessment using VAS on a scale of 0-100 (0 indicating no pain and 100 indicating severe pain); HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and errands/chores and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); hsCRP.
Measured: Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Measured: Baseline, Week 12
Percentage of Participants Who Achieve SDAI ≤ 11 at Week 12
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). Higher score indicates more severe disease activity status and total possible score is 0 to 86.
Measured: Week 12
Percentage of Participants Who Achieve CDAI ≤ 10 at Week 12
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.
Measured: Week 12
Percentage of Participants Who Achieve DAS28(CRP) ≤ 3.2 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), SGA and hsCRP measurement for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.
Measured: Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and errands/chores). Responses are scored on a 4-point Likert scale from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The need for aids or help from another person will also be recorded. The HAQ-DI total score ranges from 0 to 3 with higher scores indicating greater dysfunction. Negative change from baseline indicates improvement (less disability).
Measured: Baseline, Week 12
Percentage of Participants Who Achieve SDAI ≤ 3.3 at Week 12
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). Higher score indicates more severe disease activity status and total possible score is 0 to 86.
Measured: Week 12
Percentage of Participants Who Achieve CDAI ≤ 2.8 at Week 12
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no disease activity and maximum disease activity) and SGA assessed using VAS on a scale of 0-10 (0 and 10 indicating no arthritis and extremely active arthritis). CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.
Measured: Week 12
Percentage of Participants Who Achieve DAS28(CRP) < 2.6 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), SGA, and hsCRP measurement for a total possible score of 1 to 9.4. Higher values indicate higher disease activity.
Measured: Week 12
Pharmacokinetic (PK) Parameter: AUCtau of GS-5718
AUCtau is defined as the area under the curve from time zero to end of dosing interval.
Measured: Up to Week 12
PK Parameter: AUCtau of Methotrexate (MTX)
AUCtau is defined as the area under the curve from time zero to end of dosing interval.
Measured: Up to Week 8
PK Parameter: Cmax of GS-5718
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to Week 12
PK Parameter: Cmax of MTX
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2022Mar 2023

First posted21 Dec 2021
Study startJul 2022 (estimated)
Primary completionFeb 2023 (estimated)
Study completionMar 2023 (estimated)

Why it stopped: Sponsor decision to withdraw study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05165771
Sponsor's protocol ID: GS-US-561-5898
Other IDs: 2021-002664-52
Status last verified: May 2022
First submitted: 8 Dec 2021
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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R-2487 in Patients With Sjogren's Syndrome (SjD)
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. 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-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
ClinicalTrials.gov ID: NCT05165771
Acronym / sponsor ID: GS-US-561-5898
Conditions: Rheumatoid Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Sponsor decision to withdraw study.
Enrolment: 0 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jul 2022 (estimated)
Primary completion: Feb 2023 (estimated)
Study completion: Mar 2023 (estimated)
First posted: 21 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
GS-5718 Dose A	Experimental	Drug: GS-5718, Drug: Placebo to match GS-5718, Drug: Placebo to match TofacitinibParticipants 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 Dose B	Experimental	Drug: GS-5718, Drug: Placebo to match GS-5718, Drug: Placebo to match TofacitinibParticipants will receive GS-5718 Dose B once daily + PTM GS-5718 Dose A once daily + PTM tofacitinib twice daily for up to 12 weeks.
Tofacitinib	Active comparator	Drug: Placebo to match GS-5718, Drug: Tofacitinib 5 mgParticipants will receive tofacitinib 5 mg twice daily + PTM GS-5718 (Dose A + Dose B) once daily for up to 12 weeks.
Placebo	Placebo comparator	Drug: Placebo to match GS-5718, Drug: Placebo to match TofacitinibParticipants will receive PTM GS-5718 (Dose A + Dose B) once daily + PTM tofacitinib twice daily for up to 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.

Key exclusion criteria (3 listed)

Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.
Prior exposure to any Janus kinase inhibitor
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-5718Tablets administered orally	Drug	GS-5718 Dose A
GS-5718Tablets administered orally	Drug	GS-5718 Dose B
Placebo to match GS-5718Tablets administered orally	Drug	GS-5718 Dose A, GS-5718 Dose B, Placebo, Tofacitinib
Tofacitinib 5 mgAlso: XELJANZ®Tablets administered orally	Drug	Tofacitinib
Placebo to match TofacitinibTablets administered orally	Drug	GS-5718 Dose A, GS-5718 Dose B, Placebo

Primary outcome

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

16 secondary outcomes

Percentage of Participants Who Achieve American College of Rheumatology 20% Improvement (ACR20) Response at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve ACR 50% Improvement (ACR50) Response at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve ACR 70% Improvement (ACR70) Response at Week 12
Time frame: Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Who Achieve SDAI ≤ 11 at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve CDAI ≤ 10 at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve DAS28(CRP) ≤ 3.2 at Week 12
Time frame: Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
Time frame: Baseline, Week 12
Percentage of Participants Who Achieve SDAI ≤ 3.3 at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve CDAI ≤ 2.8 at Week 12
Time frame: Week 12
Percentage of Participants Who Achieve DAS28(CRP) < 2.6 at Week 12
Time frame: Week 12
Pharmacokinetic (PK) Parameter: AUCtau of GS-5718
Time frame: Up to Week 12
PK Parameter: AUCtau of Methotrexate (MTX)
Time frame: Up to Week 8
PK Parameter: Cmax of GS-5718
Time frame: Up to Week 12
PK Parameter: Cmax of MTX
Time frame: Up to Week 8

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Gilead Clinical Trials WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GS-5718 and Tofacitinib 5 mg in people with Rheumatoid Arthritis, run by Gilead Sciences.

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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 (DAS) Based on 28 Joints Using C-reactive Protein (CRP) 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?

On the ClinicalTrials.gov record for NCT05165771.

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 18 May 2022.