Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis
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
1 other identifier
interventional
47
1 country
27
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Oct 2013
Typical duration for phase_2 rheumatoid-arthritis
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2013
CompletedFirst Posted
Study publicly available on registry
November 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJuly 31, 2017
July 1, 2017
2.3 years
October 29, 2013
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology Criteria for a 20% improvement (ACR 20)
Percentage of participants with an American College of Rheumatology ≥20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from Baseline are met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein
Week 4
Secondary Outcomes (3)
Number of participants with adverse events
Up to 8 Weeks
American College of Rheumatology Criteria for a 50% improvement (ACR 50)
Week 4
American College of Rheumatology Criteria for a 70% improvement (ACR 70)
Week 4
Study Arms (2)
CC-292 375mg
EXPERIMENTALTreatment
Placebo
PLACEBO COMPARATORControl
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (27)
Achieve Clinical Research LLC
Birmingham, Alabama, 35216, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85023, United States
Generations Medical Research
Hot Springs, Arkansas, 71913, United States
UCLA
Los Angeles, California, 90095, United States
Joao Nascimento, MD
Bridgeport, Connecticut, 6606, United States
Southeastern Integrated Medical
Gainesville, Florida, 32607, United States
Family Arthritis Center
Jupiter, Florida, 33458, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Integral Rheumatology and Immunology specialists
Plantation, Florida, 33324, United States
Columbia Medical Practice
Columbia, Maryland, 21045, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Arthritis and Osteoporosis Associates
Freehold, New Jersey, 07728, United States
Albuquerque Clinic
Albuquerque, New Mexico, 87102, United States
NYU Langone Medical Center
New York, New York, 10016, United States
DJL Clinical Research
Charlotte, North Carolina, 28210, United States
Lynn Health Science Instiute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
PMG Research of Charlotte LLC
Rock Hill, South Carolina, 29732, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Ramesh C Gupta MD
Memphis, Tennessee, 38119, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
DM Clinical Research
Houston, Texas, 77070, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
Gundersen Clinic Ltd
Onalaska, Wisconsin, 54650, United States
Related Publications (1)
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.
PMID: 31721017DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Douglas Hough, MD, MBA
Celgene Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2013
First Posted
November 4, 2013
Study Start
October 1, 2013
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
July 31, 2017
Record last verified: 2017-07