Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis
REALISTIC
A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.
2 other identifiers
interventional
1,648
7 countries
181
Brief Summary
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jul 2008
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 15, 2008
CompletedFirst Posted
Study publicly available on registry
July 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
May 6, 2011
CompletedAugust 1, 2018
March 1, 2012
1.7 years
July 15, 2008
March 10, 2011
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology 20% (ACR20) Response at Week 12
ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)
Baseline, Week 12
Secondary Outcomes (39)
American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.
Baseline, Week 12
American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.
Baseline, Week 12
American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use
Baseline, Week 12
American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use
Baseline, Week 12
American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years
Baseline, Week 12
- +34 more secondary outcomes
Study Arms (2)
Certolizumab pegol (CZP)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Placebo (0.9% saline) given as 2 subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by placebo given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially available.
Eligibility Criteria
You may qualify if:
- Adult patient with established moderate to severe rheumatoid arthritis
You may not qualify if:
- All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (181)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Montgomery, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Fullerton, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Palm Desert, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Barbara, California, United States
Unknown Facility
Santa Maria, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
Whittier, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Lewes, Delaware, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Delray Beach, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Tavares, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Coeur d'Alene, Idaho, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Rock Island, Illinois, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Covington, Louisiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Columbia, Maryland, United States
Unknown Facility
Frederick, Maryland, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Fall River, Massachusetts, United States
Unknown Facility
Battle Creek, Michigan, United States
Unknown Facility
Kalamazoo, Michigan, United States
Unknown Facility
Lansing, Michigan, United States
Unknown Facility
Petoskey, Michigan, United States
Unknown Facility
Duluth, Minnesota, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Orchard Park, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Roslyn, New York, United States
Unknown Facility
Smithtown, New York, United States
Unknown Facility
Syracuse, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Monroe, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Fairfield, Ohio, United States
Unknown Facility
Mayfield, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Erie, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
West Reading, Pennsylvania, United States
Unknown Facility
Wexford, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Lubbock, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Sugar Land, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Newport News, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Yakima, Washington, United States
Unknown Facility
Clarksburg, West Virginia, United States
Unknown Facility
Glendale, Wisconsin, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Monroe, Wisconsin, United States
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Kitchener, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Windsor, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Rimouski, Quebec, Canada
Unknown Facility
Trois-Rivires, Quebec, Canada
Unknown Facility
Calgary, Canada
Unknown Facility
Mississauga, Canada
Unknown Facility
Newmarket, Canada
Unknown Facility
Sainte-Foy, Canada
Unknown Facility
Amiens, France
Unknown Facility
Cahors, France
Unknown Facility
Corbeil-Essonnes, France
Unknown Facility
Dreux, France
Unknown Facility
Liévin, France
Unknown Facility
Montpellier, France
Unknown Facility
Mulhouse, France
Unknown Facility
Nantes, France
Unknown Facility
Orléans, France
Unknown Facility
Paris, France
Unknown Facility
Pierre-Bénite, France
Unknown Facility
Rennes, France
Unknown Facility
Saint-Priest-en-Jarez, France
Unknown Facility
Bad Neuenahr, Germany
Unknown Facility
Baden, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Chemnitz, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Duisburg, Germany
Unknown Facility
Erfurt, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Friedrichroda, Germany
Unknown Facility
Goslar, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hildesheim, Germany
Unknown Facility
Hoyerswerda, Germany
Unknown Facility
Jena, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
München, Germany
Unknown Facility
Neuss, Germany
Unknown Facility
Osnabrück, Germany
Unknown Facility
Rostock, Germany
Unknown Facility
Wiesbaden, Germany
Unknown Facility
Zerbst, Germany
Unknown Facility
Bologna, Italy
Unknown Facility
Genova, Italy
Unknown Facility
Iesi, Italy
Unknown Facility
Modena, Italy
Unknown Facility
Palermo, Italy
Unknown Facility
Pisa, Italy
Unknown Facility
Prato, Italy
Unknown Facility
Siena, Italy
Unknown Facility
Udine, Italy
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Arnhem, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
The Hague, Netherlands
Unknown Facility
A Coruña, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Murcia, Spain
Unknown Facility
Oviedo, Spain
Unknown Facility
Pontevedra, Spain
Unknown Facility
Sabadell, Spain
Unknown Facility
Salamanca, Spain
Unknown Facility
San Cristóbal de La Laguna, Spain
Unknown Facility
Santander, Spain
Unknown Facility
Santiago de Compostela, Spain
Unknown Facility
Torrelavega, Spain
Related Publications (4)
Smolen JS, Mikuls TR, Galloway J, Muller-Ladner U, Curtis JR, Hashimoto M, Takeuchi T, Choy E, Tanaka Y, Cara C, Lauwerys B, Tilt N, Ufuktepe B, Taylor PC. Do high rheumatoid factor levels impact response to certolizumab pegol in patients with inadequately controlled rheumatoid arthritis? A post hoc analysis of the phase IIIb REALISTIC trial. RMD Open. 2026 Jan 30;12(1):e006094. doi: 10.1136/rmdopen-2025-006094.
PMID: 41617358DERIVEDPope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.
PMID: 26614481DERIVEDWeinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.
PMID: 26568428DERIVEDWeinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.
PMID: 22923753DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 15, 2008
First Posted
July 17, 2008
Study Start
July 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2011
Last Updated
August 1, 2018
Results First Posted
May 6, 2011
Record last verified: 2012-03