Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:October 2013
End Date:March 2016

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A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis

CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid
arthritis an autoimmune inflammatory disorder.

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

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled,
proof-of-concept study to determine the efficacy and safety of CC-292 (375 mg PO daily) on a
stable background of MTX therapy in female subjects with active RA.

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

Inclusion Criteria:

- Female between 18 and 80 years of age (inclusive) at the time of signing the informed
consent.

- 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:

- Male subjects

- 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.
We found this trial at
27
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Hot Springs, Arkansas 71913
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
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Albuquerque, New Mexico 87102
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Austin, Texas 78731
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Bridgeport, Connecticut 06606
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28210
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Clarksburg, West Virginia 26301
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Columbia, Maryland 21045
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Duncansville, Pennsylvania 16635
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Freehold, New Jersey 07728
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Gainesville, Florida 32607
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Houston, Texas 77070
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Jackson, Tennessee 38305
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Jupiter, Florida 33458
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Los Angeles, California 90095
(310) 825-4321
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Memphis, Tennessee 38119
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New York, New York 10016
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Ocala, Florida 34474
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Oklahoma City, Oklahoma 73112
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Onalaska, Wisconsin 54650
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Rock Hill, South Carolina 29732
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Worcester, Massachusetts 01610
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