A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Incyte

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: INCB018424; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550043

INCB 18424-231

Details and patient eligibility

About

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Established diagnosis of rheumatoid arthritis
2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.

Exclusion criteria

1. Patients who have taken the following drugs within the timeframe below:

   • Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
   • Rituximab - Within 12 months prior to the first dose of study medication;
   • Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;

2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups, including a placebo group

Cohort 1: Treatment Group A

Experimental group

Description:

INCB018424 15 mg twice daily (BID) or matching placebo

Treatment:

Drug: INCB018424

Cohort 2: Treatment Group B

Experimental group

Description:

INCB018424 5 mg BID or matching placebo

Treatment:

Drug: INCB018424

Cohort 2: Treatment Group C

Experimental group

Description:

INCB018424 25 mg BID or matching placebo

Treatment:

Drug: INCB018424

Cohort 2: Treatment Group D

Experimental group

Description:

INCB018424 50 mg once daily (QD) or matching placebo

Treatment:

Drug: INCB018424

Placebo

Placebo Comparator group

Description:

Matching placebo, oral

Treatment:

Drug: Placebo