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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT01975610

Run by

Celgene

People needed

47

Starts

2013-10-01

Expected to finish

2016-02-01

Last updated by the study team

2017-07-31

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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+

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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