Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    c87075
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00844285
Recruitment Status : Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
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 3045 patients and it's objective is to monitor patients for approximately 8 years.

Condition or disease Intervention/treatment
Crohn's Disease Drug: Cimzia

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 3045 participants
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
Actual Study Start Date : January 2009
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
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).



Primary Outcome Measures :
  1. Incidence rate of Adverse Events (AEs) of interest during the study (approximately 8 years) [ Time Frame: Approximately 8 years ]

    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).


  2. Recurrence of Adverse Events (AEs) of interest during the study (approximately 8 years) [ Time Frame: Approximately 8 years ]

    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).


  3. Time to Adverse Event (AE) of interest during the study (approximately 8 years) [ Time Frame: Approximately 8 years ]
    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 :
  1. Change from Baseline in Harvey Bradshaw Index (HBI) total score yearly (up to 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]
    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.

  2. Change from Baseline in Physician's assessment of disease yearly (up to 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]
  3. Change from Baseline in Patient's assessment of disease yearly (up to 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (CD)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844285


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
C87075 198
Birmingham, Alabama, United States
C87075 931
Birmingham, Alabama, United States
C87075 286
Huntsville, Alabama, United States
C87075 032
Montgomery, Alabama, United States
United States, Arizona
C87075 253
Scottsdale, Arizona, United States
C87075 307
Tucson, Arizona, United States
C87075 377
Tucson, Arizona, United States
United States, Arkansas
C87075 574
North Little Rock, Arkansas, United States
United States, California
C87075 059
Beverly Hills, California, United States
C87075 411
Encinitas, California, United States
C87075 021
Fountain Valley, California, United States
C87075 261
La Jolla, California, United States
C87075 220
Los Angeles, California, United States
C87075 728
Oceanside, California, United States
C87075 571
Palm Springs, California, United States
C87075 485
San Carlos, California, United States
C87075 027
Torrance, California, United States
C87075 580
Van Nuys, California, United States
United States, Colorado
C87075 946
Boulder, Colorado, United States
C87075 491
Lonetree, Colorado, United States
United States, Connecticut
C87075 087
Hamden, Connecticut, United States
C87075 077
Hartford, Connecticut, United States
C87075 097
Torrington, Connecticut, United States
United States, Florida
C87075 639
Altamonte Springs, Florida, United States
C87075 049
Boca Raton, Florida, United States
C87075 871
Boca Raton, Florida, United States
C87075 002
Gainesville, Florida, United States
C87075 759
Hialeah, Florida, United States
C87075 893
Hollywood, Florida, United States
C87075 143
Lakeland, Florida, United States
C87075 970
Largo, Florida, United States
C87075 030
Lauderdale Lakes, Florida, United States
C87075 009
Maitland, Florida, United States
C87075 003
Miami, Florida, United States
C87075 004
Miami, Florida, United States
C87075 102
Miami, Florida, United States
C87075 420
Miami, Florida, United States
C87075 034
Naples, Florida, United States
C87075 031
Orlando, Florida, United States
C87075 487
Orlando, Florida, United States
C87075 935
Orlando, Florida, United States
C87075 074
Palm Coast, Florida, United States
C87075 183
Sarasota, Florida, United States
C87075 144
Tampa, Florida, United States
C87075 046
Titusville, Florida, United States
C87075 271
Vero Beach, Florida, United States
C87075 280
Weston, Florida, United States
C87075 729
Winter Park, Florida, United States
United States, Georgia
C87075 288
Atlanta, Georgia, United States
C87075 399
Atlanta, Georgia, United States
C87075 849
Atlanta, Georgia, United States
C87075 232
Covington, Georgia, United States
C87075 357
Cumming, Georgia, United States
C87075 113
Decatur, Georgia, United States
C87075 336
Decatur, Georgia, United States
C87075 988
Decatur, Georgia, United States
C87075 698
Johns Creek, Georgia, United States
C87075 083
Lawrenceville, Georgia, United States
C87075 067
Macon, Georgia, United States
C87075 897
Macon, Georgia, United States
C87075 488
Marietta, Georgia, United States
United States, Idaho
C87075 229
Boise, Idaho, United States
C87075 245
Idaho Falls, Idaho, United States
C87075 037
Meridian, Idaho, United States
United States, Illinois
C87075 278
Arlington Heights, Illinois, United States
C87075 168
Chicago, Illinois, United States
C87075 418
Chicago, Illinois, United States
C87075 858
Evanston, Illinois, United States
C87075 208
Hoffman Estates, Illinois, United States
C87075 368
Oak Lawn, Illinois, United States
C87075 370
Oakbrook Terrace, Illinois, United States
United States, Indiana
C87075 124
Indianapolis, Indiana, United States
C87075 151
Indianapolis, Indiana, United States
United States, Iowa
C87075 343
Clive, Iowa, United States
United States, Kentucky
C87075 204
Lexington, Kentucky, United States
United States, Louisiana
C87075 072
Baton Rouge, Louisiana, United States
C87075 214
Hammond, Louisiana, United States
C87075 108
Metairie, Louisiana, United States
C87075 997
New Orleans, Louisiana, United States
C87075 987
Shreveport, Louisiana, United States
United States, Maryland
C87075 040
Annapolis, Maryland, United States
C87075 235
Annapolis, Maryland, United States
C87075 181
Baltimore, Maryland, United States
C87075 953
Baltimore, Maryland, United States
C87075 591
Towson, Maryland, United States
United States, Massachusetts
C87075 091
Boston, Massachusetts, United States
C87075 567
Boston, Massachusetts, United States
C87075 395
Newton, Massachusetts, United States
C87075 939
North Adams, Massachusetts, United States
United States, Michigan
C87075 869
Ann Arbor, Michigan, United States
C87075 260
Chesterfield, Michigan, United States
C87075 195
Kalamazoo, Michigan, United States
C87075 349
Novi, Michigan, United States
C87075 579
Troy, Michigan, United States
C87075 373
Wyandotte, Michigan, United States
C87075 167
Wyoming, Michigan, United States
C87075 843
Wyoming, Michigan, United States
C87075 829
Ypsilanti, Michigan, United States
United States, Minnesota
C87075 215
Plymouth, Minnesota, United States
C87075 501
Rochester, Minnesota, United States
United States, Mississippi
C87075 867
Ocean Springs, Mississippi, United States
United States, Missouri
C87075 540
Bridgeton, Missouri, United States
C87075 163
Columbia, Missouri, United States
C87075 776
Lee's Summit, Missouri, United States
C87075 305
Mexico, Missouri, United States
C87075 085
Saint Louis, Missouri, United States
C87075 835
Saint Louis, Missouri, United States
United States, Nevada
C87075 937
Las Vegas, Nevada, United States
United States, New Hampshire
C87075 740
Lebanon, New Hampshire, United States
C87075 323
Nashua, New Hampshire, United States
United States, New Jersey
C87075 005
Cherry Hill, New Jersey, United States
C87075 705
Egg Harbor Township, New Jersey, United States
C87075 930
Marlton, New Jersey, United States
C87075 610
Mays Landing, New Jersey, United States
C87075 161
Ridgewood, New Jersey, United States
C87075 165
Woodbury, New Jersey, United States
United States, New York
C87075 024
Brooklyn, New York, United States
C87075 362
Flushing, New York, United States
C87075 413
Great Neck, New York, United States
C87075 517
Great Neck, New York, United States
C87075 321
Jericho, New York, United States
C87075 541
Lake Success, New York, United States
C87075 018
New York, New York, United States
C87075 118
New York, New York, United States
C87075 494
New York, New York, United States
C87075 712
New York, New York, United States
C87075 159
Poughkeepsie, New York, United States
C87075 300
Rochester, New York, United States
C87075 884
Stony Brook, New York, United States
United States, North Carolina
C87075 051
Asheville, North Carolina, United States
C87075 636
Chapel Hill, North Carolina, United States
C87075 185
Charlotte, North Carolina, United States
C87075 965
Charlotte, North Carolina, United States
C87075 945
Concord, North Carolina, United States
C87075 973
Fayetteville, North Carolina, United States
C87075 527
Greenville, North Carolina, United States
C87075 127
Kinston, North Carolina, United States
C87075 926
New Bern, North Carolina, United States
C87075 779
Rocky Mount, North Carolina, United States
C87075 932
Wilmington, North Carolina, United States
United States, North Dakota
C87075 955
Bismarck, North Dakota, United States
United States, Ohio
C87075 239
Canton, Ohio, United States
C87075 807
Canton, Ohio, United States
C87075 016
Cincinnati, Ohio, United States
C87075 042
Cincinnati, Ohio, United States
C87075 462
Cleveland, Ohio, United States
C87075 314
Lima, Ohio, United States
C87075 929
Mentor, Ohio, United States
United States, Oklahoma
C87075 172
Tulsa, Oklahoma, United States
C87075 777
Tulsa, Oklahoma, United States
United States, Oregon
C87075 213
Portland, Oregon, United States
United States, Pennsylvania
C87075 947
Allentown, Pennsylvania, United States
C87075 241
Hermitage, Pennsylvania, United States, 16148
C87075 460
Malvern, Pennsylvania, United States
C87075 166
Philadelphia, Pennsylvania, United States
C87075 086
Pittsburgh, Pennsylvania, United States
United States, South Carolina
C87075 176
Charleston, South Carolina, United States
C87075 813
Columbia, South Carolina, United States
United States, South Dakota
C87075 922
Sioux Falls, South Dakota, United States
United States, Tennessee
C87075 299
Franklin, Tennessee, United States
C87075 262
Hermitage, Tennessee, United States
C87075 757
Jackson, Tennessee, United States
C87075 224
Knoxville, Tennessee, United States
C87075 390
Nashville, Tennessee, United States
C87075 894
Nashville, Tennessee, United States
C87075 596
Union City, Tennessee, United States
United States, Texas
C87075 200
Austin, Texas, United States
C87075 272
Austin, Texas, United States
C87075 628
Dallas, Texas, United States
C87075 941
Dallas, Texas, United States
C87075 088
Fort Sam Houston, Texas, United States
C87075 226
Fort Worth, Texas, United States
C87075 237
Houston, Texas, United States
C87075 419
Houston, Texas, United States
C87075 726
Houston, Texas, United States
C87075 312
Pasadena, Texas, United States
C87075 657
San Antonio, Texas, United States
C87075 923
San Antonio, Texas, United States
C87075 279
Southlake, Texas, United States
C87075 366
Temple, Texas, United States
C87075 539
Tyler, Texas, United States
United States, Utah
C87075 986
Salt Lake City, Utah, United States
United States, Vermont
C87075 814
Burlington, Vermont, United States
C87075 963
Colchester, Vermont, United States
United States, Virginia
C87075 675
Christiansburg, Virginia, United States
C87075 691
Norfolk, Virginia, United States
C87075 446
Richmond, Virginia, United States
C87075 026
Virginia Beach, Virginia, United States
C87075 273
Woodbridge, Virginia, United States
United States, Washington
C87075 471
Seattle, Washington, United States
C87075 925
Tacoma, Washington, United States
United States, Wisconsin
C87075 465
Green Bay, Wisconsin, United States
C87075 116
Madison, Wisconsin, United States
C87075 070
Milwaukee, Wisconsin, United States
C87075 281
Milwaukee, Wisconsin, United States
C87075 389
Milwaukee, Wisconsin, United States
C87075 578
Milwaukee, Wisconsin, United States
C87075 093
Oshkosh, Wisconsin, United States
Sponsors and Collaborators
UCB Pharma
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 844 599 2273(UCB)

Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00844285     History of Changes
Other Study ID Numbers: C87075
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents