A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
{ "A Study of Tulisokibart for Rheumatoid Arthritis", "Researchers are studying a new treatment called tulisokibart for people with active rheumatoid arthritis (RA) who are already taking methotrexate (MTX). MTX is a common RA treatment, but it doesn't work for everyone. This study aims to see if tulisokibart, given as an injection under the skin, can better reduce RA symptoms compared to a placebo (a substance that looks like the study medicine but has no active drug). You may be able to join if you are 18 to 80 years old, have a diagnosis of RA, and have at least 6 tender and 6 swollen joints. The main goal is to see what percentage of participants achieve a 20% improvement in their RA symptoms after 12 weeks.", "design": "This is an interventional study with a planned enrollment of 182 participants. It includes a placebo-controlled period to compare tulisokibart against a placebo.", "commitments": "The study involves a 12-week placebo-controlled period, followed by a long-term extension that can last up to 116 weeks. Methotrexate will be given as background therapy, either by injection under the skin or by mouth.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for at least 12 weeks to measure the primary outcome, with an optional extension period of up to 116 weeks.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
At a glance
Conditions
Where it's being run
62 sites across 48 statesStudy leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12Week 12
The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.