SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
SECURE
A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease
1 other identifier
observational
3,072
1 country
197
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
197 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
January 30, 2009
CompletedFirst Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2020
CompletedResults Posted
Study results publicly available
May 6, 2023
CompletedMay 6, 2023
April 1, 2023
11.6 years
February 13, 2009
June 14, 2022
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules)
Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without). Adverse events of interest included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Treatment groups are based upon actual treatment conservatively assigning participant time and events to CZP even after stopping CZP. Data for malignant or unspecified tumor as per malignancy rules has been reported in this outcome measure.
Baseline up to 10 years
Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules)
Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without an event of interest). Adverse events of interest (AEoI) included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Data for AEoIs as per acute event rules has been reported in this outcome measure where the AEoI is assigned to the treatment the participant is on at the time of the event.
Baseline up to 10 years
Secondary Outcomes (4)
Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline
Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment
Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline
Study Arms (2)
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.
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).
Interventions
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Eligibility Criteria
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.
You may qualify if:
- Patient must have medically documented Crohn's disease (CD)
- Patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (197)
C87075 931
Birmingham, Alabama, 35209, United States
C87075 198
Birmingham, Alabama, 35233, United States
C87075 286
Huntsville, Alabama, 35802, United States
C87075 032
Montgomery, Alabama, 36116, United States
C87075 253
Scottsdale, Arizona, 85260, United States
C87075 307
Tucson, Arizona, 85710, United States
C87075 377
Tucson, Arizona, 85724, United States
C87075 574
North Little Rock, Arkansas, 72117, United States
C87075 059
Beverly Hills, California, 90211, United States
C87075 580
Encino, California, 91436, United States
C87075 021
Fountain Valley, California, 92708, United States
C87075 261
La Jolla, California, 92037, United States
C87075 220
Los Angeles, California, 90027, United States
C87075 728
Oceanside, California, 92056, United States
C87075 571
Palm Springs, California, 92262, United States
C87075 485
San Carlos, California, 94070, United States
C87075 027
Torrance, California, 90505, United States
C87075 946
Boulder, Colorado, 80304, United States
C87075 491
Lonetree, Colorado, 80124, United States
C87075 087
Hamden, Connecticut, 06518, United States
C87075 077
Hartford, Connecticut, 06106, United States
C87075 097
Torrington, Connecticut, 06790, United States
C87075 639
Altamonte Springs, Florida, 32701, United States
C87075 049
Boca Raton, Florida, 33428, United States
C87075 871
Boca Raton, Florida, 33486, United States
C87075 002
Gainesville, Florida, 32610, United States
C87075 759
Hialeah, Florida, 33016, United States
C87075 893
Hollywood, Florida, United States
C87075 143
Lakeland, Florida, 33805, United States
C87075 970
Largo, Florida, 33777, United States
C87075 030
Lauderdale Lakes, Florida, 33319, United States
C87075 009
Maitland, Florida, 32751, United States
C87075 003
Miami, Florida, 33136, United States
C87075 004
Miami, Florida, 33156, United States
C87075 102
Miami, Florida, 33156, United States
C87075 420
Miami, Florida, 33156, United States
C87075 034
Naples, Florida, 34102, United States
C87075 031
Orlando, Florida, 32803, United States
C87075 487
Orlando, Florida, 32803, United States
C87075 935
Orlando, Florida, 32819, United States
C87075 074
Palm Coast, Florida, 32164, United States
C87075 183
Sarasota, Florida, 34239, United States
C87075 144
Tampa, Florida, 33626, United States
C87075 046
Titusville, Florida, 32796, United States
C87075 271
Vero Beach, Florida, 32960, United States
C87075 280
Weston, Florida, 33331, United States
C87075 729
Winter Park, Florida, 32789, United States
C87075 399
Atlanta, Georgia, 30322, United States
C87075 288
Atlanta, Georgia, 30342, United States
C87075 849
Atlanta, Georgia, 30342, United States
C87075 232
Covington, Georgia, 30014, United States
C87075 357
Cumming, Georgia, 30041, United States
C87075 336
Decatur, Georgia, 30032, United States
C87075 113
Decatur, Georgia, 30033, United States
C87075 988
Decatur, Georgia, 30033, United States
C87075 698
Johns Creek, Georgia, 30342, United States
C87075 083
Lawrenceville, Georgia, 30045, United States
C87075 067
Macon, Georgia, 31201, United States
C87075 897
Macon, Georgia, 31210, United States
C87075 488
Marietta, Georgia, 30067, United States
C87075 229
Boise, Idaho, 83712, United States
C87075 245
Idaho Falls, Idaho, 83404, United States
C87075 037
Meridian, Idaho, 83702, United States
C87075 278
Arlington Heights, Illinois, 60005, United States
C87075 418
Chicago, Illinois, 60612, United States
C87075 168
Chicago, Illinois, 60637, United States
C87075 858
Evanston, Illinois, 60201, United States
C87075 208
Hoffman Estates, Illinois, 60169, United States
C87075 368
Oak Lawn, Illinois, 60453, United States
C87075 370
Oakbrook Terrace, Illinois, 60181, United States
C87075 151
Indianapolis, Indiana, 46202, United States
C87075 124
Indianapolis, Indiana, 46237, United States
C87075 343
Clive, Iowa, 50325, United States
C87075 204
Lexington, Kentucky, 40536, United States
C87075 072
Baton Rouge, Louisiana, 70808, United States
C87075 214
Hammond, Louisiana, 70403, United States
C87075 108
Metairie, Louisiana, 70006, United States
C87075 997
New Orleans, Louisiana, 70121, United States
C87075 987
Shreveport, Louisiana, 71103, United States
C87075 235
Annapolis, Maryland, 21041, United States
C87075 040
Annapolis, Maryland, 21401, United States
C87075 181
Baltimore, Maryland, 21201, United States
C87075 953
Baltimore, Maryland, 21202, United States
C87075 591
Towson, Maryland, 21204, United States
C87075 091
Boston, Massachusetts, 02111, United States
C87075 567
Boston, Massachusetts, 02215, United States
C87075 395
Newton, Massachusetts, 02114, United States
C87075 939
North Adams, Massachusetts, 01247, United States
C87075 869
Ann Arbor, Michigan, 48109, United States
C87075 260
Chesterfield, Michigan, 48047, United States
C87075 195
Kalamazoo, Michigan, 49048, United States
C87075 349
Novi, Michigan, 48377, United States
C87075 579
Troy, Michigan, 48098, United States
C87075 373
Wyandotte, Michigan, 48192, United States
C87075 167
Wyoming, Michigan, 49519, United States
C87075 843
Wyoming, Michigan, 49519, United States
C87075 829
Ypsilanti, Michigan, 48197, United States
C87075 215
Plymouth, Minnesota, 55446, United States
C87075 501
Rochester, Minnesota, 55905, United States
C87075 867
Ocean Springs, Mississippi, 39564, United States
C87075 540
Bridgeton, Missouri, 63044, United States
C87075 163
Columbia, Missouri, 65201, United States
C87075 776
Lee's Summit, Missouri, 64064, United States
C87075 305
Mexico, Missouri, 65256, United States
C87075 085
St Louis, Missouri, 63117, United States
C87075 835
St Louis, Missouri, 63141, United States
C87075 937
Las Vegas, Nevada, 89109, United States
C87075 740
Lebanon, New Hampshire, 03756, United States
C87075 323
Nashua, New Hampshire, 03060, United States
C87075 005
Cherry Hill, New Jersey, 08053, United States
C87075 705
Egg Harbor, New Jersey, 08234, United States
C87075 930
Marlton, New Jersey, 08053, United States
C87075 610
Mays Landing, New Jersey, 08330, United States
C87075 161
Ridgewood, New Jersey, 07450, United States
C87075 165
Woodbury, New Jersey, 08096, United States
C87075 024
Brooklyn, New York, 11235, United States
C87075 362
Flushing, New York, 11355, United States
C87075 413
Great Neck, New York, 11021, United States
C87075 517
Great Neck, New York, 11042, United States
C87075 321
Jericho, New York, 11753, United States
C87075 541
Lake Success, New York, 11042, United States
C87075 118
New York, New York, 10021, United States
C87075 712
New York, New York, 10021, United States
C87075 494
New York, New York, 10028, United States
C87075 018
New York, New York, 10032, United States
C87075 159
Poughkeepsie, New York, 12601, United States
C87075 300
Rochester, New York, 14621, United States
C87075 884
Stony Brook, New York, 11794, United States
C87075 051
Asheville, North Carolina, 28801, United States
C87075 636
Chapel Hill, North Carolina, 27599, United States
C87075 185
Charlotte, North Carolina, 28210, United States
C87075 965
Charlotte, North Carolina, 28211, United States
C87075 945
Concord, North Carolina, 28025, United States
C87075 973
Fayetteville, North Carolina, 28304, United States
C87075 527
Greenville, North Carolina, 27834, United States
C87075 127
Kinston, North Carolina, 28501, United States
C87075 926
New Bern, North Carolina, 28562, United States
C87075 779
Rocky Mount, North Carolina, 27804, United States
C87075 932
Wilmington, North Carolina, 28401, United States
C87075 955
Bismarck, North Dakota, 58501, United States
C87075 239
Canton, Ohio, 44718, United States
C87075 807
Canton, Ohio, 44718, United States
C87075 042
Cincinnati, Ohio, 45249, United States
C87075 016
Cincinnati, Ohio, 45267, United States
C87075 462
Cleveland, Ohio, 44195, United States
C87075 314
Lima, Ohio, 45806, United States
C87075 929
Mentor, Ohio, 44060, United States
C87075 777
Tulsa, Oklahoma, 74104, United States
C87075 172
Tulsa, Oklahoma, 74135, United States
C87075 213
Portland, Oregon, 97225, United States
C87075 947
Allentown, Pennsylvania, 18104, United States
C87075 241
Hermitage, Pennsylvania, 16148, United States
C87075 460
Malvern, Pennsylvania, 19301, United States
C87075 166
Philadelphia, Pennsylvania, 19104, United States
C87075 086
Pittsburgh, Pennsylvania, 15213, United States
C87075 176
Charleston, South Carolina, 29425, United States
C87075 813
Columbia, South Carolina, 29169, United States
C87075 922
Sioux Falls, South Dakota, 57108, United States
C87075 299
Franklin, Tennessee, 37067, United States
C87075 262
Hermitage, Tennessee, 37076, United States
C87075 757
Jackson, Tennessee, 38308, United States
C87075 224
Knoxville, Tennessee, 37934, United States
C87075 390
Nashville, Tennessee, 37205, United States
C87075 894
Nashville, Tennessee, 37232, United States
C87075 596
Union City, Tennessee, 38261, United States
C87075 272
Austin, Texas, 78705, United States
C87075 200
Austin, Texas, 78758, United States
C87075 941
Dallas, Texas, 75230, United States
C87075 628
Dallas, Texas, 75231, United States
C87075 088
Fort Sam Houston, Texas, 78234, United States
C87075 226
Fort Worth, Texas, 76104, United States
C87075 237
Houston, Texas, 77030, United States
C87075 419
Houston, Texas, 77030, United States
C87075 726
Houston, Texas, 77030, United States
C87075 312
Pasadena, Texas, 77505, United States
C87075 657
San Antonio, Texas, 78229, United States
C87075 923
San Antonio, Texas, 78258, United States
C87075 279
Southlake, Texas, 76051, United States
C87075 366
Temple, Texas, 76508, United States
C87075 539
Tyler, Texas, 75701, United States
C87075 986
Salt Lake City, Utah, 84132, United States
C87075 814
Burlington, Vermont, 05401, United States
C87075 963
Colchester, Vermont, 05401, United States
C87075 675
Christiansburg, Virginia, 24073, United States
C87075 691
Norfolk, Virginia, 23502, United States
C87075 446
Richmond, Virginia, 23298, United States
C87075 026
Virginia Beach, Virginia, 23454, United States
C87075 273
Woodbridge, Virginia, 22192, United States
C87075 471
Seattle, Washington, 98195, United States
C87075 925
Tacoma, Washington, 98405, United States
C87075 465
Green Bay, Wisconsin, 54307, United States
C87075 116
Madison, Wisconsin, 53792, United States
C87075 070
Milwaukee, Wisconsin, 53209, United States
C87075 281
Milwaukee, Wisconsin, 53215, United States
C87075 389
Milwaukee, Wisconsin, 53226, United States
C87075 578
Milwaukee, Wisconsin, 53226, United States
C87075 093
Oshkosh, Wisconsin, 54904, United States
Related Publications (1)
Lichtenstein GR, Lee SD, Feagan BG, Loftus EV Jr, Ng S, Dehlin K, Quinn P, Coarse J, Rosario-Jansen T, Arendt C, Stark JL. Certolizumab Pegol Treatment in Patients With Crohn's Disease: Final Safety Data From the SECURE Registry. Crohns Colitis 360. 2025 Jan 25;7(1):otae083. doi: 10.1093/crocol/otae083. eCollection 2025 Jan.
PMID: 39895830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273(UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
January 30, 2009
Primary Completion
August 21, 2020
Study Completion
August 21, 2020
Last Updated
May 6, 2023
Results First Posted
May 6, 2023
Record last verified: 2023-04