Crohn's Disease Clinical Trial
— SECUREOfficial title:
A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease
| NCT number | NCT00844285 |
| Other study ID # | C87075 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 30, 2009 |
| Est. completion date | August 21, 2020 |
| Verified date | April 2023 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3072 |
| Est. completion date | August 21, 2020 |
| Est. primary completion date | August 21, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | C87075 947 | Allentown | Pennsylvania |
| United States | C87075 639 | Altamonte Springs | Florida |
| United States | C87075 869 | Ann Arbor | Michigan |
| United States | C87075 040 | Annapolis | Maryland |
| United States | C87075 235 | Annapolis | Maryland |
| United States | C87075 278 | Arlington Heights | Illinois |
| United States | C87075 051 | Asheville | North Carolina |
| United States | C87075 288 | Atlanta | Georgia |
| United States | C87075 399 | Atlanta | Georgia |
| United States | C87075 849 | Atlanta | Georgia |
| United States | C87075 200 | Austin | Texas |
| United States | C87075 272 | Austin | Texas |
| United States | C87075 181 | Baltimore | Maryland |
| United States | C87075 953 | Baltimore | Maryland |
| United States | C87075 072 | Baton Rouge | Louisiana |
| United States | C87075 059 | Beverly Hills | California |
| United States | C87075 198 | Birmingham | Alabama |
| United States | C87075 931 | Birmingham | Alabama |
| United States | C87075 955 | Bismarck | North Dakota |
| United States | C87075 049 | Boca Raton | Florida |
| United States | C87075 871 | Boca Raton | Florida |
| United States | C87075 229 | Boise | Idaho |
| United States | C87075 091 | Boston | Massachusetts |
| United States | C87075 567 | Boston | Massachusetts |
| United States | C87075 946 | Boulder | Colorado |
| United States | C87075 540 | Bridgeton | Missouri |
| United States | C87075 024 | Brooklyn | New York |
| United States | C87075 814 | Burlington | Vermont |
| United States | C87075 239 | Canton | Ohio |
| United States | C87075 807 | Canton | Ohio |
| United States | C87075 636 | Chapel Hill | North Carolina |
| United States | C87075 176 | Charleston | South Carolina |
| United States | C87075 185 | Charlotte | North Carolina |
| United States | C87075 965 | Charlotte | North Carolina |
| United States | C87075 005 | Cherry Hill | New Jersey |
| United States | C87075 260 | Chesterfield | Michigan |
| United States | C87075 168 | Chicago | Illinois |
| United States | C87075 418 | Chicago | Illinois |
| United States | C87075 675 | Christiansburg | Virginia |
| United States | C87075 016 | Cincinnati | Ohio |
| United States | C87075 042 | Cincinnati | Ohio |
| United States | C87075 462 | Cleveland | Ohio |
| United States | C87075 343 | Clive | Iowa |
| United States | C87075 963 | Colchester | Vermont |
| United States | C87075 163 | Columbia | Missouri |
| United States | C87075 813 | Columbia | South Carolina |
| United States | C87075 945 | Concord | North Carolina |
| United States | C87075 232 | Covington | Georgia |
| United States | C87075 357 | Cumming | Georgia |
| United States | C87075 628 | Dallas | Texas |
| United States | C87075 941 | Dallas | Texas |
| United States | C87075 113 | Decatur | Georgia |
| United States | C87075 336 | Decatur | Georgia |
| United States | C87075 988 | Decatur | Georgia |
| United States | C87075 705 | Egg Harbor Township | New Jersey |
| United States | C87075 580 | Encino | California |
| United States | C87075 858 | Evanston | Illinois |
| United States | C87075 973 | Fayetteville | North Carolina |
| United States | C87075 362 | Flushing | New York |
| United States | C87075 088 | Fort Sam Houston | Texas |
| United States | C87075 226 | Fort Worth | Texas |
| United States | C87075 021 | Fountain Valley | California |
| United States | C87075 299 | Franklin | Tennessee |
| United States | C87075 002 | Gainesville | Florida |
| United States | C87075 413 | Great Neck | New York |
| United States | C87075 517 | Great Neck | New York |
| United States | C87075 465 | Green Bay | Wisconsin |
| United States | C87075 527 | Greenville | North Carolina |
| United States | C87075 087 | Hamden | Connecticut |
| United States | C87075 214 | Hammond | Louisiana |
| United States | C87075 077 | Hartford | Connecticut |
| United States | C87075 241 | Hermitage | Pennsylvania |
| United States | C87075 262 | Hermitage | Tennessee |
| United States | C87075 759 | Hialeah | Florida |
| United States | C87075 208 | Hoffman Estates | Illinois |
| United States | C87075 893 | Hollywood | Florida |
| United States | C87075 237 | Houston | Texas |
| United States | C87075 419 | Houston | Texas |
| United States | C87075 726 | Houston | Texas |
| United States | C87075 286 | Huntsville | Alabama |
| United States | C87075 245 | Idaho Falls | Idaho |
| United States | C87075 124 | Indianapolis | Indiana |
| United States | C87075 151 | Indianapolis | Indiana |
| United States | C87075 757 | Jackson | Tennessee |
| United States | C87075 321 | Jericho | New York |
| United States | C87075 698 | Johns Creek | Georgia |
| United States | C87075 195 | Kalamazoo | Michigan |
| United States | C87075 127 | Kinston | North Carolina |
| United States | C87075 224 | Knoxville | Tennessee |
| United States | C87075 261 | La Jolla | California |
| United States | C87075 541 | Lake Success | New York |
| United States | C87075 143 | Lakeland | Florida |
| United States | C87075 970 | Largo | Florida |
| United States | C87075 937 | Las Vegas | Nevada |
| United States | C87075 030 | Lauderdale Lakes | Florida |
| United States | C87075 083 | Lawrenceville | Georgia |
| United States | C87075 740 | Lebanon | New Hampshire |
| United States | C87075 776 | Lee's Summit | Missouri |
| United States | C87075 204 | Lexington | Kentucky |
| United States | C87075 314 | Lima | Ohio |
| United States | C87075 491 | Lonetree | Colorado |
| United States | C87075 220 | Los Angeles | California |
| United States | C87075 067 | Macon | Georgia |
| United States | C87075 897 | Macon | Georgia |
| United States | C87075 116 | Madison | Wisconsin |
| United States | C87075 009 | Maitland | Florida |
| United States | C87075 460 | Malvern | Pennsylvania |
| United States | C87075 488 | Marietta | Georgia |
| United States | C87075 930 | Marlton | New Jersey |
| United States | C87075 610 | Mays Landing | New Jersey |
| United States | C87075 929 | Mentor | Ohio |
| United States | C87075 037 | Meridian | Idaho |
| United States | C87075 108 | Metairie | Louisiana |
| United States | C87075 305 | Mexico | Missouri |
| 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 070 | Milwaukee | Wisconsin |
| United States | C87075 281 | Milwaukee | Wisconsin |
| United States | C87075 389 | Milwaukee | Wisconsin |
| United States | C87075 578 | Milwaukee | Wisconsin |
| United States | C87075 032 | Montgomery | Alabama |
| United States | C87075 034 | Naples | Florida |
| United States | C87075 323 | Nashua | New Hampshire |
| United States | C87075 390 | Nashville | Tennessee |
| United States | C87075 894 | Nashville | Tennessee |
| United States | C87075 926 | New Bern | North Carolina |
| United States | C87075 997 | New Orleans | Louisiana |
| 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 395 | Newton | Massachusetts |
| United States | C87075 691 | Norfolk | Virginia |
| United States | C87075 939 | North Adams | Massachusetts |
| United States | C87075 574 | North Little Rock | Arkansas |
| United States | C87075 349 | Novi | Michigan |
| United States | C87075 368 | Oak Lawn | Illinois |
| United States | C87075 370 | Oakbrook Terrace | Illinois |
| United States | C87075 867 | Ocean Springs | Mississippi |
| United States | C87075 728 | Oceanside | California |
| United States | C87075 031 | Orlando | Florida |
| United States | C87075 487 | Orlando | Florida |
| United States | C87075 935 | Orlando | Florida |
| United States | C87075 093 | Oshkosh | Wisconsin |
| United States | C87075 074 | Palm Coast | Florida |
| United States | C87075 571 | Palm Springs | California |
| United States | C87075 312 | Pasadena | Texas |
| United States | C87075 166 | Philadelphia | Pennsylvania |
| United States | C87075 086 | Pittsburgh | Pennsylvania |
| United States | C87075 215 | Plymouth | Minnesota |
| United States | C87075 213 | Portland | Oregon |
| United States | C87075 159 | Poughkeepsie | New York |
| United States | C87075 446 | Richmond | Virginia |
| United States | C87075 161 | Ridgewood | New Jersey |
| United States | C87075 300 | Rochester | New York |
| United States | C87075 501 | Rochester | Minnesota |
| United States | C87075 779 | Rocky Mount | North Carolina |
| United States | C87075 085 | Saint Louis | Missouri |
| United States | C87075 835 | Saint Louis | Missouri |
| United States | C87075 986 | Salt Lake City | Utah |
| United States | C87075 657 | San Antonio | Texas |
| United States | C87075 923 | San Antonio | Texas |
| United States | C87075 485 | San Carlos | California |
| United States | C87075 183 | Sarasota | Florida |
| United States | C87075 253 | Scottsdale | Arizona |
| United States | C87075 471 | Seattle | Washington |
| United States | C87075 987 | Shreveport | Louisiana |
| United States | C87075 922 | Sioux Falls | South Dakota |
| United States | C87075 279 | Southlake | Texas |
| United States | C87075 884 | Stony Brook | New York |
| United States | C87075 925 | Tacoma | Washington |
| United States | C87075 144 | Tampa | Florida |
| United States | C87075 366 | Temple | Texas |
| United States | C87075 046 | Titusville | Florida |
| United States | C87075 027 | Torrance | California |
| United States | C87075 097 | Torrington | Connecticut |
| United States | C87075 591 | Towson | Maryland |
| United States | C87075 579 | Troy | Michigan |
| United States | C87075 307 | Tucson | Arizona |
| United States | C87075 377 | Tucson | Arizona |
| United States | C87075 172 | Tulsa | Oklahoma |
| United States | C87075 777 | Tulsa | Oklahoma |
| United States | C87075 539 | Tyler | Texas |
| United States | C87075 596 | Union City | Tennessee |
| United States | C87075 271 | Vero Beach | Florida |
| United States | C87075 026 | Virginia Beach | Virginia |
| United States | C87075 280 | Weston | Florida |
| United States | C87075 932 | Wilmington | North Carolina |
| United States | C87075 729 | Winter Park | Florida |
| United States | C87075 273 | Woodbridge | Virginia |
| United States | C87075 165 | Woodbury | New Jersey |
| United States | C87075 373 | Wyandotte | Michigan |
| United States | C87075 167 | Wyoming | Michigan |
| United States | C87075 843 | Wyoming | Michigan |
| United States | C87075 829 | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| UCB BIOSCIENCES, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | HBI measured 5 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications [1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess]. The total HBI score was sum of all the 5 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | |
| Secondary | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | HBI response determined based on patient reported HBI total scores was defined as a drop of at least 3 points from baseline HBI total score. Patient reported HBI was composed of 4 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), and whether there are any complications [1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess]. The total HBI score was sum of all the 4 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. | 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 | |
| Secondary | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Physician assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | |
| Secondary | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Patient assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. | 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 |
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