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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:May 2009
End Date:July 2010

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A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

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.


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, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or
cerebral disease

- Subjects who have received treatment with the following drugs or drug classes within
the specified timeframe: prior treatment with rituximab within 12 months, prior
treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic
therapies not specified and allowed according to protocol, treatment with any
investigational medication within 12 weeks or 5 half-lives (whichever is longer), and
treatment with a biologic agent within 12 weeks prior to the first dose of study
medication

- Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring
transfusion other than at the time of trauma or surgery, and subjects that meet
protocol specified laboratory measures
We found this trial at
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