Rheumatoid ArthritisPhase 2NCT07895524
A Clinical Trial of MK-8690 in Participants With Rheumatoid Arthritis (MK-8690-004)
A Phase 2 study testing MK-8690 and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC.
Trial summary
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. 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?
- MK-8690 and Methotrexate (MTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2026to 28 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The main inclusion criteria include but are not limited to the following:
- Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
- Has current treatment with oral or parenteral methotrexate (MTX) therapy
- Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-inadequate response (IR)/intolerant up to a maximum of 1 class of bDMARD
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc.), or any other condition that may interfere with the assessment of RA
- Has a transplanted organ and requires continued systemic immunosuppression
- Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization
- Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- Has an active infection
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Participants With Rheumatoid Arthritis
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. Researchers are doing this trial to learn if a trial medicine called MK-8690 can treat symptoms of active RA in people who are taking MTX.
The goal of this study is to learn if MK-8690 works better than placebo to improve RA symptoms.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MK-8690, Placebo, Methotrexate (MTX)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8690Combination product
Also called PRA052
Solution for SC injection
PlaceboCombination product
Solution for SC injection
Methotrexate (MTX)Drug
Background therapy - variable dose strength with route of administration per approved product label
| Study group | Role | What they receive |
|---|---|---|
| Period 1: MK-8690 | Experimental | Participant will receive MK-8690 subcutaneous (SC) for 12 weeks Receives: Combination Product: MK-8690; Drug: Methotrexate (MTX) |
| Period 1: Placebo | Placebo comparator | Participant will receive placebo SC for 12 weeks Receives: Combination Product: Placebo; Drug: Methotrexate (MTX) |
| Extension Period | Experimental | After completing Period 1 participants will receive MK-8690 SC for 40 weeks. Receives: Combination Product: MK-8690; Drug: Methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
ACR response is a well-established composite measure used in clinical trials to evaluate clinical response in rheumatoid arthritis (RA). ACR50 response is defined as 50% or greater improvement in tender joint count (TJC) based on 68 joints, swollen joint count (SJC) based on 66 joints, and ≥3 of the 5 remaining components of Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment of Disease Activity (PGA), Patient Global Assessment of Disease Activity (PtGA), Patient Assessment of Pain Severity, and high-sensitivity C-reactive protein (hsCRP). ACR50 is an accepted measure by the FDA to demonstrate reduction in RA disease activity and is defined as the proportion of participants achieving 50% improvement in the composite measure. The percentage of participants achieving ACR50 at Week 12 will be presented.
Measured: Week 12
Secondary outcomes (9)
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience 1 or more AEs will be presented.
Measured: Up to approximately 70 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be presented.
Measured: Up to approximately 48 weeks
Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
ACR20 response is defined as 20% or greater improvement in TJC based on 68 joints, SJC based on 66 joints, and ≥3 of the 5 remaining components of HAQ-DI, PGA, PtGA, Patient Assessment of Pain Severity, and hsCRP. ACR20 is an accepted measure by the FDA to demonstrate reduction in RA disease activity and is defined as the proportion of participants achieving 20% improvement in the composite measure. The percentage of participants achieving ACR20 at Week 12 will be presented.
Measured: Week 12
Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
ACR70 response is defined as 70% or greater improvement in TJC based on 68 joints, SJC based on 66 joints, and ≥3 of the 5 remaining components of HAQ-DI, PGA, PtGA, Patient Assessment of Pain Severity, and hsCRP. ACR70 is an accepted measure by the FDA to demonstrate reduction in RA disease activity and is defined as the proportion of participants achieving 70% improvement in the composite measure. The percentage of participants achieving ACR70 at Week 70 will be presented.
Measured: Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP) at Week 12
The DAS28-CRP is a continuous composite measure of RA activity that includes the following components:
- TJC (out of a total of 28 joints)
- SJC (out of a total of 28 joints)
- hsCRP
- PtGA The 28 anatomical joints for inclusion in the TJC and SJC scoring are the shoulders, elbows, wrists, first through fifth metacarpophalangeals, second through fifth proximal interphalangeals, thumb interphalangeals, and knees. The DAS28-CRP score ranges from 0 to 10, with higher scores indicating a higher degree of disease activity. LDA is indicated by a DAS28-CRP score of ≤3.2. The percentage of participants achieving LDA at Week 12 will be presented.
Measured: Week 12
Change from Baseline in DAS28-CRP
The DAS28-CRP is a continuous composite measure of RA activity that includes the following components:
- TJC (out of a total of 28 joints)
- SJC (out of a total of 28 joints)
- hsCRP
- PtGA The 28 anatomical joints for inclusion in the TJC and SJC scoring are the shoulders, elbows, wrists, first through fifth metacarpophalangeals, second through fifth proximal interphalangeals, thumb interphalangeals, and knees. The DAS28-CRP score ranges from 0 to 10, with higher scores indicating a higher degree of disease activity. The change from Baseline at designated timepoints up to Week 52 in the DAS28-CRP will be presented.
Measured: Baseline and at designated timepoints up to Week 52
Percentage of Participants Achieving LDA based on DAS28-CRP
The DAS28-CRP is a continuous composite measure of RA disease activity that includes the following components:
- TJC (out of a total of 28 joints)
- SJC (out of a total of 28 joints)
- hsCRP
- PtGA The 28 anatomical joints for inclusion in the TJC and SJC scoring are the shoulders, elbows, wrists, first through fifth metacarpophalangeals, second through fifth proximal interphalangeals, thumb interphalangeals, and knees. The DAS28-CRP score ranges from 0 to 10, with higher scores indicating a higher degree of disease activity. Remission is indicated by a DAS28-CRP score of <2.6 and LDA by a DAS28-CRP score of ≤3.2. The percentage of participants achieving LDA at designated timepoints up to Week 52 based on DAS28-CRP will be presented.
Measured: At designated timepoints up to Week 52
Percentage of Participants Achieving Clinical Remission Based on DAS28-CRP
The DAS28-CRP is a continuous composite measure of RA disease activity that includes the following components:
- TJC (out of a total of 28 joints)
- SJC (out of a total of 28 joints)
- hsCRP
- PtGA The 28 anatomical joints for inclusion in the TJC and SJC scoring are the shoulders, elbows, wrists, first through fifth metacarpophalangeals, second through fifth proximal interphalangeals, thumb interphalangeals, and knees. The DAS28-CRP score ranges from 0 to 10, with higher scores indicating a higher degree of disease activity. Remission is indicated by a DAS28-CRP score of <2.6 and LDA by a DAS28-CRP score of ≤3.2. The percentage of participants achieving clinical remission at designated timepoints assessed up to Week 52 based on DAS28-CRP will be presented.
Measured: At designated timepoints assessed up to Week 52
Change From Baseline in the HAQ-DI Score
HAQ-DI is measure of physical function in RA clinical trials and is a 20-item questionnaire completed by the participant. The measure includes 8 domains assessing "dressing and grooming," "arising," "eating," "walking," "hygiene," "reach," "grip," and "activities." Participants respond on a 4-point scale ranging from 0 = "without ANY difficulty" to 3 = "UNABLE to do." The measure also captures the use of aids or devices and need for help from another person. The overall disability score is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3 (worst disability). Clinically meaningful improvement in HAQ-DI for RA has been determined to be ≥0.22 points. The change from Baseline to Week 12 in the HAQ-DI will be presented.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start23 Nov 2026 (estimated)
- Primary completion19 Oct 2027 (estimated)
- Study completion28 Nov 2028 (estimated)
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 Merck Sharp & Dohme LLCThe 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
- Model description
- Double Blind: Placebo-controlled Treatment Period Open Label: Extension Period
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895524
- Sponsor's protocol ID
- 8690-004
- Other IDs
- MK-8690-004
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Participants With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07895524
- Acronym / sponsor ID
- 8690-004
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 19 Oct 2027 (estimated)
- Study completion
- 28 Nov 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. Researchers are doing this trial to learn if a trial medicine called MK-8690 can treat symptoms of active RA in people who are taking MTX.
The goal of this study is to learn if MK-8690 works better than placebo to improve RA symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double Blind: Placebo-controlled Treatment Period Open Label: Extension Period
| Arm | Type | Receives |
|---|---|---|
| Period 1: MK-8690 | Experimental | Combination Product: MK-8690, Drug: Methotrexate (MTX)Participant will receive MK-8690 subcutaneous (SC) for 12 weeks |
| Period 1: Placebo | Placebo comparator | Combination Product: Placebo, Drug: Methotrexate (MTX)Participant will receive placebo SC for 12 weeks |
| Extension Period | Experimental | Combination Product: MK-8690, Drug: Methotrexate (MTX)After completing Period 1 participants will receive MK-8690 SC for 40 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
- Has current treatment with oral or parenteral methotrexate (MTX) therapy
- Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-inadequate response (IR)/intolerant up to a maximum of 1 class of bDMARD
Key exclusion criteria (6 listed)
- Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc.), or any other condition that may interfere with the assessment of RA
- Has a transplanted organ and requires continued systemic immunosuppression
- Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization
- Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
- Has an active infection
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 |
|---|---|---|
| MK-8690Also: PRA052Solution for SC injection | Combination product | Extension Period, Period 1: MK-8690 |
| PlaceboSolution for SC injection | Combination product | Period 1: Placebo |
| Methotrexate (MTX)Background therapy - variable dose strength with route of administration per approved product label | Drug | Extension Period, Period 1: MK-8690, Period 1: Placebo |
Primary outcome
Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
Time frame: Week 12
ACR response is a well-established composite measure used in clinical trials to evaluate clinical response in rheumatoid arthritis (RA). ACR50 response is defined as 50% or greater improvement in tender joint count (TJC) based on 68 joints, swollen joint count (SJC) based on 66 joints, and ≥3 of the 5 remaining components of Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment of Disease Activity (PGA), Patient Global Assessment of Disease Activity (PtGA), Patient Assessment of Pain Severity, and high-sensitivity C-reactive protein (hsCRP). ACR50 is an accepted measure by the FDA to demonstrate reduction in RA disease activity and is defined as the proportion of participants achieving 50% improvement in the composite measure. The percentage of participants achieving ACR50 at Week 12 will be presented.
9 secondary outcomes
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 70 weeks
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 48 weeks
Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Time frame: Week 12
Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
Time frame: Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP) at Week 12
Time frame: Week 12
Change from Baseline in DAS28-CRP
Time frame: Baseline and at designated timepoints up to Week 52
Percentage of Participants Achieving LDA based on DAS28-CRP
Time frame: At designated timepoints up to Week 52
Percentage of Participants Achieving Clinical Remission Based on DAS28-CRP
Time frame: At designated timepoints assessed up to Week 52
Change From Baseline in the HAQ-DI Score
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-8690 and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12 (time frame: 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 26 Oct 2026.