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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00902486
First received: May 13, 2009
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: INCB028050
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Safety and tolerability of INCB028050 as measured by adverse events, vital signs, clinical laboratory tests and ECGs. [ Time Frame: 3 months of Treatment ] [ Designated as safety issue: No ]
  • Efficacy as determined by percent of subjects achieving ACR 20 improvement. [ Time Frame: 3 month of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of INCB028050 as measured by adverse events, vital signs, clinical laboratory tests and ECGs. [ Time Frame: 6 months of Treatment ] [ Designated as safety issue: No ]
  • Efficacy as determined by percent of subjects achieving ACR 20, 50, 70 and 90 improvement. [ Time Frame: 6 months of Treatment ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
INCB028050 4mg QD
Drug: INCB028050
4 mg capsules QD
Experimental: 2
INCB028050 7mg QD
Drug: INCB028050
7 mg capsules QD
Experimental: 3
INCB028050 10mg QD
Drug: INCB028050
10 mg capsule QD
Placebo Comparator: 4
Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.
Drug: Placebo
Placebo matching INCB028050 QD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 10 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: ESR greater than or equal to 28 mm/hr or CRP greater than or equal to 10 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902486

  Show 49 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Monica E. Luchi, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00902486     History of Changes
Other Study ID Numbers: INCB 28050-201
Study First Received: May 13, 2009
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014