Active Rheumatoid Arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: INCB028050 phosphate
Product Code: INCB028050
Pharmaceutical Form: Capsule*
Current Sponsor code: INCB028050 phosphate
Other descriptive name: INCB028050 phosphate salt
Concentration uni
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included in the study if they are: 1. Male or female subjects over 18 years of age (or the legal age of consent, whichever is older). 2. Females may be enrolled following a negative urine pregnancy test. Subjects must agree to take appropriate precautions to avoid pregnancy or fathering a child (with at least 99% certainty) from screening through follow-up. (Note: Permitted methods which are at least 99% effective in preventing pregnancy should be communicated to the subjects and their understanding confirmed). 3. Have an established diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Criteria 4. Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD including gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, cholorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil, methotrexate, leflunomide, sulfasalazine or a biologic. 5. For subjects receiving antimalarials (hydroxychloroquine, chloroquine or quinacrine), they must be treated with antimalarials for at least 6 months, and receiving a stable daily dose (hydroxychloroquine no more than 200 mg BID, chloroquine no more than 250 mg QD, or quinacrine no more than 100 mg QD) for at least 8 consecutive weeks prior to randomization. 6. For subjects receiving sulfasalazine, they must be treated with SSZ for at least 6 months, and receiving a stable daily dose of no more than 3 grams per day for at least 8 consecutive weeks prior to randomization. 7. 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 per week for at least 8 consecutive weeks prior to study entry. 8. 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 per day for at least 8 consecutive weeks prior to randomization. 9. For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily (or equivalent) and on a stable dose for at least 6 weeks prior to randomization. 10. 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: o ESR above 28 mm/hr. o CRP above 10 mg/liter. 11. Have evidence of lack of risk for tuberculosis, as determined by one of the following: - Negative PPD test (< 5 mm induration) or, for subjects with a history of BCG vaccination within the 10 years prior to Screening, a negative chest X-ray, or - Negative QuantiFERON-TB Gold test - Note that if both tests are done, both must be negative. 12. Have negative serology tests for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). (Note: Subjects with a negative HBsAg and a positive HBcAb may be permitted in the study if they also have a positive hepatitis B surface antibody (HBsAb) and normal hepatic transaminases. 13. Have negative serology tests for hepatitis C virus antibody (HCVAb). 14. Have negative serology tests for human immunodeficiency virus antibody (HIVAb). 15. Be able and willing to provide written, informed consent. 16. Be able and willing to comply, in the opinion of the investigator, with the requirements of this study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they have: 1. Current or recent ( 38 kg/m2) or asthenic (BMI 460 msec. 16. Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects with the following laboratory parameters at Screening: - Hemoglobin < 10.0 g/dL. - White blood cell (WBC) count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary Objectives of this study are to determine the: • Safety and tolerability of 3 months of dosing of INCB028050 in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy. • Efficacy of INCB028050 at 3 months in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy.;Secondary Objective: The Secondary Objectives of this study are to determine the: • Safety and tolerability of 6 months of dosing of INCB028050 in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy. • Efficacy of INCB028050 at 6 months in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy. • Population pharmacokinetics (PK) of INCB028050 in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy. • Effect of INCB028050 on additional non-genotypic pharmacodynamic markers of rheumatoid disease activity in patients with active rheumatoid arthritis who have had inadequate response to any DMARD therapy.;Primary end point(s): 1. Safety and tolerability of INCB028050 as measured by adverse events, vital signs, clinical laboratory tests and ECGs after 3 months of treatment. 2. Efficacy as determined by percent of subjects achieving ACR 20 improvement at 3 months. | — |
Countries
Czech Republic
Outcome results
None listed