CompletedPhase 2

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

United States, Czechia127 participantsStarted 2009-05

Plain-language summary

This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD * For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day * For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg * For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg * For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily * Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter * Have evidence of lack of risk for tuberculosis Exclusion Criteria: * Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy * History of infected joint prosthesis * Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement

Timeframe: Week 12

Participants With at Least 1 Adverse Event From Baseline Through Week 12

Timeframe: From Baseline through week 12

Trial details

NCT IDNCT00902486

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2018-06-10

View on ClinicalTrials.gov More Rheumatoid Arthritis trials