Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis
NCT ID: NCT01975610
Last Updated: 2017-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2013-10-31
2016-02-29
Brief Summary
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This study will test the clinical effectiveness and safety of an orally (PO) administered dose of CC-292 compared to placebo in US female patients currently on background Methotrexate (MTX) with active Rheumatoid Arthritis (RA
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Detailed Description
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Approximately 80 female subjects with active RA will be randomized 1:1 into two dose groups: active CC-292 (375 mg PO daily) or identically-appearing placebo capsules for 4 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CC-292 375mg
Treatment
CC-292
375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days)
Placebo
Control
Placebo
Twice daily for 28 days
Interventions
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CC-292
375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days)
Placebo
Twice daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Must meet the 2010 ACR/EULAR Classification Criteria for RA (Appendix A), have RA for at least 6 months and must continue to have active RA at the time of randomization despite at least 3 months of treatment with stable doses of MTX (7.5 to 25 mg/week oral or parenteral) for at least 4 weeks prior to randomization.
* Must have been treated with MTX for at least 3 months prior to randomization, and must be on a stable dose between 7.5 and 25 mg/week (PO or parenteral, not both) for at least 4 weeks prior to randomization. Subjects will be required to maintain their stable dose through Day 28/Week 4 of the study. Oral folate supplementation is required with a minimum dose of 5 mg/week (ie, folic acid) while the subject is taking MTX. Leucovorin may be used instead of folic acid and may be dosed up to 10 mg/week orally.
* Sulfasalazine is allowed as a concomitant medication, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through Day 28/Week 4 of the study.
* Hydroxychloroquine or chloroquine is allowed as concomitant medications, however, subject must be on a stable dose for at least 4 weeks prior to randomization and through Day 28/Week 4 of the study.
* Modification of Diet in Renal Disease formula (MDRD) estimated glomerular filtration rate (MDRD eGFR) ≥ 60 mL/min/1.73m2+
Exclusion Criteria
* Any condition that could affect CC-292 absorption, including gastric restrictions, bariatric surgery, such as gastric bypass, and clinical conditions that are associated with decreased intragastric acid production such as acid pernicious anemia.
* Currently using treatment with DMARDs (other than sulfasalazine, hydroxychloroquine or chloroquine and MTX), including biologics. Previous use is only allowed after adequate washout (4 weeks or 5 half-lives, whichever is longer) prior to randomization.
* Previous treatment with any cell depleting therapies, including investigational agents (eg, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20) within 6 months of screening.
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba® column within 2 weeks prior to randomization.
* Intra-articular or parenteral corticosteroids are not allowed within 2 weeks prior to randomization.
18 Years
80 Years
FEMALE
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Hough, MD, MBA
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Achieve Clinical Research LLC
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
Generations Medical Research
Hot Springs, Arkansas, United States
UCLA
Los Angeles, California, United States
Joao Nascimento, MD
Bridgeport, Connecticut, United States
Southeastern Integrated Medical
Gainesville, Florida, United States
Family Arthritis Center
Jupiter, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Integral Rheumatology and Immunology specialists
Plantation, Florida, United States
Columbia Medical Practice
Columbia, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Arthritis and Osteoporosis Associates
Freehold, New Jersey, United States
Albuquerque Clinic
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Lynn Health Science Instiute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
PMG Research of Charlotte LLC
Rock Hill, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh C Gupta MD
Memphis, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
DM Clinical Research
Houston, Texas, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Gundersen Clinic Ltd
Onalaska, Wisconsin, United States
Countries
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References
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Schafer PH, Kivitz AJ, Ma J, Korish S, Sutherland D, Li L, Azaryan A, Kosek J, Adams M, Capone L, Hur EM, Hough DR, Ringheim GE. Spebrutinib (CC-292) Affects Markers of B Cell Activation, Chemotaxis, and Osteoclasts in Patients with Rheumatoid Arthritis: Results from a Mechanistic Study. Rheumatol Ther. 2020 Mar;7(1):101-119. doi: 10.1007/s40744-019-00182-7. Epub 2019 Nov 13.
Other Identifiers
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CC-292-RA-001
Identifier Type: -
Identifier Source: org_study_id
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