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SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00844285
First received: February 13, 2009
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 4000 patients and it's objective is to monitor patients for approximately 10 years.


Condition Intervention
Crohn's Disease
Drug: Cimzia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Incidence rate of Adverse Events (AEs) of interest during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]

    AEs of interest include: autoimmune disorders, demyelinating disorders, serious infections or opportunistic infections, lymphoma and other malignancies, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).

    Incidence rate is defined as the number of patients experiencing the event of interest divided by the number person-years without an event (time up to the event for patients experiencing an event, and the full study time for those without an event of interest).


  • Recurrence of Adverse Events (AEs) of interest during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]

    AEs of interest include: autoimmune disorders, demyelinating disorders, serious infections or opportunistic infections, lymphoma and other malignancies, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).

    Recurrence rate is defined as the number of patients experiencing a recurrence of the event of interest divided by the number person-years without a recurrence (time up to the recurrence event for patients experiencing an recurrence, and the full study time for those without a recurrence).


  • Time to Adverse Event (AE) of interest during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
    AEs of interest include: autoimmune disorders, demyelinating disorders, serious infections or opportunistic infections, lymphoma and other malignancies, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).


Secondary Outcome Measures:
  • Change from Baseline in Harvey Bradshaw Index (HBI) total score yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ Designated as safety issue: No ]
    HBI scores consist of clinical parameters for general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (1 per item). Lower scores indicated better well-being.

  • Change from Baseline in Physician's assessment of disease yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient's assessment of disease yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: January 2009
Estimated Study Completion Date: January 2026
Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cimzia Cohort:
Patients about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's disease or has already been receiving treatment with Cimzia® for ≤12 months. Patients must also receive a Cimzia dose within 2 months following enrollment.
Drug: Cimzia
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Comparison cohort
Patient must be about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).

Detailed Description:

Physicians are expected to manage patients as they would under normal practice conditions; patients will receive and use their medications according to their normal course of medical treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of selected gastroenterologists and internal medicine physicians from both community-based and academic practice settings (75% and 25% respectively) Each physician should be able to recruit a minimum of 5 patients prescribed Cimzia® and/or 5 patients prescribed other treatments.

Recruitment into both cohorts will be monitored and controlled as needed in order to ensure balanced enrollment over time. In order to ensure reasonable balance between both cohorts, retrospective frequency matching will be applied for disease severity (mild/moderate/severe), age categories and gender.

Criteria

Inclusion Criteria:

  • Patient must have medically documented Crohn's disease
  • The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study
  • Patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data
  • Patients participating in randomized, blinded clinical trials for CD or other conditions are not eligible for inclusion into the SECURE registry. Involvement in other registries, where patients follow routine clinical practice, is permitted, however
  • For the Cimzia cohort: Patient is receiving treatment with Cimzia for the first time. Patient must receive Cimzia treatment within 2 months of enrollment into the registry
  • Patient is currently receiving treatment with Cimzia for ≤12 months. Patient must also receive a Cimzia dose within 2 months following enrollment into the registry
  • For the comparison cohort: Patient is switching CD treatment or beginning CD treatment for the first time. Previous Cimzia treatment is prohibited in the comparator group. Patient must receive new CD treatment within 2 months of enrollment into the registry. Patient is currently receiving anti-TNF treatment for ≤12 months. Patient must receive anti-TNF treatment within 2 months following enrollment into the registry. Patient is currently receiving immunosuppressant therapy for ≤12 months. Patient must receive immunosuppressant therapy within 2 months following enrollment into the registry. Patient is currently receiving systemic steroid therapy for ≤12 months. Patient must receive systemic steroid therapy within 2 months following enrollment into registry

Exclusion Criteria:

  • See inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844285

  Hide Study Locations
Locations
United States, Alabama
931
Birmingham, Alabama, United States
198
Birmingham, Alabama, United States
286
Huntsville, Alabama, United States
032
Montgomery, Alabama, United States
United States, Arizona
253
Scottsdale, Arizona, United States
307
Tucson, Arizona, United States
377
Tucson, Arizona, United States
United States, Arkansas
574
North Little Rock, Arkansas, United States
United States, California
059
Beverly Hills, California, United States
021
Fountain Valley, California, United States
261
La Jolla, California, United States
220
Los Angeles, California, United States
728
Oceanside, California, United States
571
Palm Springs, California, United States
485
San Carlos, California, United States
027
Torrance, California, United States
580
Van Nuys, California, United States
United States, Colorado
946
Boulder, Colorado, United States
491
Lonetree, Colorado, United States
United States, Connecticut
087
Hamden, Connecticut, United States
097
Torrington, Connecticut, United States
United States, Florida
639
Altamonte Springs, Florida, United States
871
Boca Raton, Florida, United States
049
Boca Raton, Florida, United States
002
Gainesville, Florida, United States
759
Hialeah, Florida, United States
893
Hollywood, Florida, United States
143
Lakeland, Florida, United States
970
Largo, Florida, United States
030
Lauderdale Lakes, Florida, United States
009
Maitland, Florida, United States
003
Miami, Florida, United States
004
Miami, Florida, United States
102
Miami, Florida, United States
034
Naples, Florida, United States
031
Orlando, Florida, United States
487
Orlando, Florida, United States
935
Orlando, Florida, United States
074
Palm Coast, Florida, United States
183
Sarasota, Florida, United States
144
Tampa, Florida, United States
046
Titusville, Florida, United States
271
Vero Beach, Florida, United States
280
Weston, Florida, United States
729
Winter Park, Florida, United States
United States, Georgia
849
Atlanta, Georgia, United States
288
Atlanta, Georgia, United States
232
Covington, Georgia, United States
357
Cumming, Georgia, United States
113
Decatur, Georgia, United States
336
Decatur, Georgia, United States
988
Decatur, Georgia, United States
698
Johns Creek, Georgia, United States
083
Lawrenceville, Georgia, United States
067
Macon, Georgia, United States
897
Macon, Georgia, United States
488
Marietta, Georgia, United States
United States, Idaho
229
Boise, Idaho, United States
245
Idaho Falls, Idaho, United States
037
Meridian, Idaho, United States
United States, Illinois
278
Arlington Heights, Illinois, United States
168
Chicago, Illinois, United States
418
Chicago, Illinois, United States
858
Evanston, Illinois, United States
208
Hoffman Estates, Illinois, United States
368
Oak Lawn, Illinois, United States
370
Oakbrook Terrace, Illinois, United States
United States, Indiana
124
Indianapolis, Indiana, United States
151
Indianapolis, Indiana, United States
United States, Iowa
343
Clive, Iowa, United States
United States, Kentucky
204
Lexington, Kentucky, United States
United States, Louisiana
072
Baton Rouge, Louisiana, United States
214
Hammond, Louisiana, United States
108
Metairie, Louisiana, United States
997
New Orleans, Louisiana, United States
987
Shreveport, Louisiana, United States
United States, Maryland
040
Annapolis, Maryland, United States
235
Annapolis, Maryland, United States
181
Baltimore, Maryland, United States
953
Baltimore, Maryland, United States
591
Towson, Maryland, United States
United States, Massachusetts
091
Boston, Massachusetts, United States
567
Boston, Massachusetts, United States
395
Newton, Massachusetts, United States
939
North Adams, Massachusetts, United States
United States, Michigan
869
Ann Arbor, Michigan, United States
260
Chesterfield, Michigan, United States
195
Kalamazoo, Michigan, United States
349
Novi, Michigan, United States
373
Wyandotte, Michigan, United States
167
Wyoming, Michigan, United States
843
Wyoming, Michigan, United States
829
Ypsilanti, Michigan, United States
United States, Minnesota
215
Plymouth, Minnesota, United States
501
Rochester, Minnesota, United States
United States, Mississippi
867
Ocean Springs, Mississippi, United States
United States, Missouri
540
Bridgeton, Missouri, United States
163
Columbia, Missouri, United States
776
Lees Summit, Missouri, United States
305
Mexico, Missouri, United States
085
St. Louis, Missouri, United States
United States, Nevada
937
Las Vegas, Nevada, United States
United States, New Hampshire
740
Lebanon, New Hampshire, United States
323
Nashua, New Hampshire, United States
United States, New Jersey
005
Cherry Hill, New Jersey, United States
705
Egg Harbor Township, New Jersey, United States
930
Marlton, New Jersey, United States
610
Mays Landing, New Jersey, United States
161
Ridgewood, New Jersey, United States
165
Woodbury, New Jersey, United States
United States, New York
024
Brooklyn, New York, United States
362
Flushing, New York, United States
413
Great Neck, New York, United States
517
Great Neck, New York, United States
541
Lake Success, New York, United States
321
Mineola, New York, United States
018
New York, New York, United States
494
New York, New York, United States
712
New York, New York, United States
118
New York, New York, United States
159
Poughkeepsie, New York, United States
300
Rochester, New York, United States
United States, North Carolina
051
Asheville, North Carolina, United States
636
Chapel Hill, North Carolina, United States
185
Charlotte, North Carolina, United States
965
Charlotte, North Carolina, United States
945
Concord, North Carolina, United States
973
Fayetteville, North Carolina, United States
527
Greenville, North Carolina, United States
127
Kinston, North Carolina, United States
926
New Bern, North Carolina, United States
779
Rocky Mount, North Carolina, United States
932
Wilmington, North Carolina, United States
United States, Ohio
239
Canton, Ohio, United States
807
Canton, Ohio, United States
016
Cincinnati, Ohio, United States
042
Cincinnati, Ohio, United States
462
Cleveland, Ohio, United States
314
Lima, Ohio, United States
929
Mentor, Ohio, United States
United States, Oklahoma
172
Tulsa, Oklahoma, United States
777
Tulsa, Oklahoma, United States
United States, Oregon
213
Portland, Oregon, United States
United States, Pennsylvania
947
Allentown, Pennsylvania, United States
241
Hermitage, Pennsylvania, United States
460
Malvern, Pennsylvania, United States
166
Philadelphia, Pennsylvania, United States
086
Pittsburgh, Pennsylvania, United States
United States, South Carolina
176
Charleston, South Carolina, United States
813
Columbia, South Carolina, United States
United States, South Dakota
922
Sioux Falls, South Dakota, United States
United States, Tennessee
262
Hermitage, Tennessee, United States
757
Jackson, Tennessee, United States
894
Nashville, Tennessee, United States
390
Nashville, Tennessee, United States
596
Union City, Tennessee, United States
United States, Texas
200
Austin, Texas, United States
272
Austin, Texas, United States
628
Dallas, Texas, United States
941
Dallas, Texas, United States
088
Fort Sam Houston, Texas, United States
226
Fort Worth, Texas, United States
237
Houston, Texas, United States
726
Houston, Texas, United States
312
Pasadena, Texas, United States
657
San Antonio, Texas, United States
923
San Antonio, Texas, United States
279
Southlake, Texas, United States
366
Temple, Texas, United States
539
Tyler, Texas, United States
United States, Utah
986
Salt Lake City, Utah, United States
United States, Vermont
814
Burlington, Vermont, United States
963
Colchester, Vermont, United States
United States, Virginia
675
Christianburg, Virginia, United States
691
Norfolk, Virginia, United States
446
Richmond, Virginia, United States
026
Virginia Beach, Virginia, United States
273
Woodbridge, Virginia, United States
United States, Washington
471
Seattle, Washington, United States
925
Tacoma, Washington, United States
United States, Wisconsin
465
Green Bay, Wisconsin, United States
116
Madison, Wisconsin, United States
281
Milwaukee, Wisconsin, United States
070
Milwaukee, Wisconsin, United States
578
Milwaukee, Wisconsin, United States
389
Milwaukee, Wisconsin, United States
093
Oshkosh, Wisconsin, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00844285     History of Changes
Other Study ID Numbers: C87075
Study First Received: February 13, 2009
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Certolizumab Pegol, Cimzia ®
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014