Clinical trial NCT00844285: SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Official title: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Certolizumab Pegol, Cimzia ®
Crohn's Disease
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-02-16
Enrollment: 3072
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules)
timeFrame: Baseline up to 10 years
measure: Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules)
timeFrame: Baseline up to 10 years
Secondary outcomes:
measure: Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
timeFrame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
measure: Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
timeFrame: 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
measure: Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment
timeFrame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
measure: Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: C87075 931
state: Alabama
city: Birmingham
country: United States
facility: C87075 198
state: Alabama
city: Huntsville
country: United States
facility: C87075 286
state: Alabama
city: Montgomery
country: United States
facility: C87075 032
state: Alabama
city: Scottsdale
country: United States
facility: C87075 253
state: Arizona
city: Tucson
country: United States
facility: C87075 307
state: Arizona
city: Tucson
country: United States
facility: C87075 377
state: Arizona
city: North Little Rock
country: United States
facility: C87075 574
state: Arkansas
city: Beverly Hills
country: United States
facility: C87075 059
state: California
city: Encino
country: United States
facility: C87075 580
state: California
city: Fountain Valley
country: United States
facility: C87075 021
state: California
city: La Jolla
country: United States
facility: C87075 261
state: California
city: Los Angeles
country: United States
facility: C87075 220
state: California
city: Oceanside
country: United States
facility: C87075 728
state: California
city: Palm Springs
country: United States
facility: C87075 571
state: California
city: San Carlos
country: United States
facility: C87075 485
state: California
city: Torrance
country: United States
facility: C87075 027
state: California
city: Boulder
country: United States
facility: C87075 946
state: Colorado
city: Lonetree
country: United States
facility: C87075 491
state: Colorado
city: Hamden
country: United States
facility: C87075 087
state: Connecticut
city: Hartford
country: United States
facility: C87075 077
state: Connecticut
city: Torrington
country: United States
facility: C87075 097
state: Connecticut
city: Altamonte Springs
country: United States
facility: C87075 639
state: Florida
city: Boca Raton
country: United States
facility: C87075 049
state: Florida
city: Boca Raton
country: United States
facility: C87075 871
state: Florida
city: Gainesville
country: United States
facility: C87075 002
state: Florida
city: Hialeah
country: United States
facility: C87075 759
state: Florida
city: Hollywood
country: United States
facility: C87075 893
state: Florida
city: Lakeland
country: United States
facility: C87075 143
state: Florida
city: Largo
country: United States
facility: C87075 970
state: Florida
city: Lauderdale Lakes
country: United States
facility: C87075 030
state: Florida
city: Maitland
country: United States
facility: C87075 009
state: Florida
city: Miami
country: United States
facility: C87075 003
state: Florida
city: Miami
country: United States
facility: C87075 004
state: Florida
city: Miami
country: United States
facility: C87075 102
state: Florida
city: Miami
country: United States
facility: C87075 420
state: Florida
city: Naples
country: United States
facility: C87075 034
state: Florida
city: Orlando
country: United States
facility: C87075 031
state: Florida
city: Orlando
country: United States
facility: C87075 487
state: Florida
city: Orlando
country: United States
facility: C87075 935
state: Florida
city: Palm Coast
country: United States
facility: C87075 074
state: Florida
city: Sarasota
country: United States
facility: C87075 183
state: Florida
city: Tampa
country: United States
facility: C87075 144
state: Florida
city: Titusville
country: United States
facility: C87075 046
state: Florida
city: Vero Beach
country: United States
facility: C87075 271
state: Florida
city: Weston
country: United States
facility: C87075 280
state: Florida
city: Winter Park
country: United States
facility: C87075 729
state: Florida
city: Atlanta
country: United States
facility: C87075 399
state: Georgia
city: Atlanta
country: United States
facility: C87075 288
state: Georgia
city: Atlanta
country: United States
facility: C87075 849
state: Georgia
city: Covington
country: United States
facility: C87075 232
state: Georgia
city: Cumming
country: United States
facility: C87075 357
state: Georgia
city: Decatur
country: United States
facility: C87075 336
state: Georgia
city: Decatur
country: United States
facility: C87075 113
state: Georgia
city: Decatur
country: United States
facility: C87075 988
state: Georgia
city: Johns Creek
country: United States
facility: C87075 698
state: Georgia
city: Lawrenceville
country: United States
facility: C87075 083
state: Georgia
city: Macon
country: United States
facility: C87075 067
state: Georgia
city: Macon
country: United States
facility: C87075 897
state: Georgia
city: Marietta
country: United States
facility: C87075 488
state: Georgia
city: Boise
country: United States
facility: C87075 229
state: Idaho
city: Idaho Falls
country: United States
facility: C87075 245
state: Idaho
city: Meridian
country: United States
facility: C87075 037
state: Idaho
city: Arlington Heights
country: United States
facility: C87075 278
state: Illinois
city: Chicago
country: United States
facility: C87075 418
state: Illinois
city: Chicago
country: United States
facility: C87075 168
state: Illinois
city: Evanston
country: United States
facility: C87075 858
state: Illinois
city: Hoffman Estates
country: United States
facility: C87075 208
state: Illinois
city: Oak Lawn
country: United States
facility: C87075 368
state: Illinois
city: Oakbrook Terrace
country: United States
facility: C87075 370
state: Illinois
city: Indianapolis
country: United States
facility: C87075 151
state: Indiana
city: Indianapolis
country: United States
facility: C87075 124
state: Indiana
city: Clive
country: United States
facility: C87075 343
state: Iowa
city: Lexington
country: United States
facility: C87075 204
state: Kentucky
city: Baton Rouge
country: United States
facility: C87075 072
state: Louisiana
city: Hammond
country: United States
facility: C87075 214
state: Louisiana
city: Metairie
country: United States
facility: C87075 108
state: Louisiana
city: New Orleans
country: United States
facility: C87075 997
state: Louisiana
city: Shreveport
country: United States
facility: C87075 987
state: Louisiana
city: Annapolis
country: United States
facility: C87075 235
state: Maryland
city: Annapolis
country: United States
facility: C87075 040
state: Maryland
city: Baltimore
country: United States
facility: C87075 181
state: Maryland
city: Baltimore
country: United States
facility: C87075 953
state: Maryland
city: Towson
country: United States
facility: C87075 591
state: Maryland
city: Boston
country: United States
facility: C87075 091
state: Massachusetts
city: Boston
country: United States
facility: C87075 567
state: Massachusetts
city: Newton
country: United States
facility: C87075 395
state: Massachusetts
city: North Adams
country: United States
facility: C87075 939
state: Massachusetts
city: Ann Arbor
country: United States
facility: C87075 869
state: Michigan
city: Chesterfield
country: United States
facility: C87075 260
state: Michigan
city: Kalamazoo
country: United States
facility: C87075 195
state: Michigan
city: Novi
country: United States
facility: C87075 349
state: Michigan
city: Troy
country: United States
facility: C87075 579
state: Michigan
city: Wyandotte
country: United States
facility: C87075 373
state: Michigan
city: Wyoming
country: United States
facility: C87075 167
state: Michigan
city: Wyoming
country: United States
facility: C87075 843
state: Michigan
city: Ypsilanti
country: United States
facility: C87075 829
state: Michigan
city: Plymouth
country: United States
facility: C87075 215
state: Minnesota
city: Rochester
country: United States
facility: C87075 501
state: Minnesota
city: Ocean Springs
country: United States
facility: C87075 867
state: Mississippi
city: Bridgeton
country: United States
facility: C87075 540
state: Missouri
city: Columbia
country: United States
facility: C87075 163
state: Missouri
city: Lee's Summit
country: United States
facility: C87075 776
state: Missouri
city: Mexico
country: United States
facility: C87075 305
state: Missouri
city: Saint Louis
country: United States
facility: C87075 085
state: Missouri
city: Saint Louis
country: United States
facility: C87075 835
state: Missouri
city: Las Vegas
country: United States
facility: C87075 937
state: Nevada
city: Lebanon
country: United States
facility: C87075 740
state: New Hampshire
city: Nashua
country: United States
facility: C87075 323
state: New Hampshire
city: Cherry Hill
country: United States
facility: C87075 005
state: New Jersey
city: Egg Harbor Township
country: United States
facility: C87075 705
state: New Jersey
city: Marlton
country: United States
facility: C87075 930
state: New Jersey
city: Mays Landing
country: United States
facility: C87075 610
state: New Jersey
city: Ridgewood
country: United States
facility: C87075 161
state: New Jersey
city: Woodbury
country: United States
facility: C87075 165
state: New Jersey
city: Brooklyn
country: United States
facility: C87075 024
state: New York
city: Flushing
country: United States
facility: C87075 362
state: New York
city: Great Neck
country: United States
facility: C87075 413
state: New York
city: Great Neck
country: United States
facility: C87075 517
state: New York
city: Jericho
country: United States
facility: C87075 321
state: New York
city: Lake Success
country: United States
facility: C87075 541
state: New York
city: New York
country: United States
facility: C87075 118
state: New York
city: New York
country: United States
facility: C87075 712
state: New York
city: New York
country: United States
facility: C87075 494
state: New York
city: New York
country: United States
facility: C87075 018
state: New York
city: Poughkeepsie
country: United States
facility: C87075 159
state: New York
city: Rochester
country: United States
facility: C87075 300
state: New York
city: Stony Brook
country: United States
facility: C87075 884
state: New York
city: Asheville
country: United States
facility: C87075 051
state: North Carolina
city: Chapel Hill
country: United States
facility: C87075 636
state: North Carolina
city: Charlotte
country: United States
facility: C87075 185
state: North Carolina
city: Charlotte
country: United States
facility: C87075 965
state: North Carolina
city: Concord
country: United States
facility: C87075 945
state: North Carolina
city: Fayetteville
country: United States
facility: C87075 973
state: North Carolina
city: Greenville
country: United States
facility: C87075 527
state: North Carolina
city: Kinston
country: United States
facility: C87075 127
state: North Carolina
city: New Bern
country: United States
facility: C87075 926
state: North Carolina
city: Rocky Mount
country: United States
facility: C87075 779
state: North Carolina
city: Wilmington
country: United States
facility: C87075 932
state: North Carolina
city: Bismarck
country: United States
facility: C87075 955
state: North Dakota
city: Canton
country: United States
facility: C87075 239
state: Ohio
city: Canton
country: United States
facility: C87075 807
state: Ohio
city: Cincinnati
country: United States
facility: C87075 042
state: Ohio
city: Cincinnati
country: United States
facility: C87075 016
state: Ohio
city: Cleveland
country: United States
facility: C87075 462
state: Ohio
city: Lima
country: United States
facility: C87075 314
state: Ohio
city: Mentor
country: United States
facility: C87075 929
state: Ohio
city: Tulsa
country: United States
facility: C87075 777
state: Oklahoma
city: Tulsa
country: United States
facility: C87075 172
state: Oklahoma
city: Portland
country: United States
facility: C87075 213
state: Oregon
city: Allentown
country: United States
facility: C87075 947
state: Pennsylvania
city: Hermitage
country: United States
facility: C87075 241
state: Pennsylvania
city: Malvern
country: United States
facility: C87075 460
state: Pennsylvania
city: Philadelphia
country: United States
facility: C87075 166
state: Pennsylvania
city: Pittsburgh
country: United States
facility: C87075 086
state: Pennsylvania
city: Charleston
country: United States
facility: C87075 176
state: South Carolina
city: Columbia
country: United States
facility: C87075 813
state: South Carolina
city: Sioux Falls
country: United States
facility: C87075 922
state: South Dakota
city: Franklin
country: United States
facility: C87075 299
state: Tennessee
city: Hermitage
country: United States
facility: C87075 262
state: Tennessee
city: Jackson
country: United States
facility: C87075 757
state: Tennessee
city: Knoxville
country: United States
facility: C87075 224
state: Tennessee
city: Nashville
country: United States
facility: C87075 390
state: Tennessee
city: Nashville
country: United States
facility: C87075 894
state: Tennessee
city: Union City
country: United States
facility: C87075 596
state: Tennessee
city: Austin
country: United States
facility: C87075 272
state: Texas
city: Austin
country: United States
facility: C87075 200
state: Texas
city: Dallas
country: United States
facility: C87075 941
state: Texas
city: Dallas
country: United States
facility: C87075 628
state: Texas
city: Fort Sam Houston
country: United States
facility: C87075 088
state: Texas
city: Fort Worth
country: United States
facility: C87075 226
state: Texas
city: Houston
country: United States
facility: C87075 237
state: Texas
city: Houston
country: United States
facility: C87075 419
state: Texas
city: Houston
country: United States
facility: C87075 726
state: Texas
city: Pasadena
country: United States
facility: C87075 312
state: Texas
city: San Antonio
country: United States
facility: C87075 657
state: Texas
city: San Antonio
country: United States
facility: C87075 923
state: Texas
city: Southlake
country: United States
facility: C87075 279
state: Texas
city: Temple
country: United States
facility: C87075 366
state: Texas
city: Tyler
country: United States
facility: C87075 539
state: Texas
city: Salt Lake City
country: United States
facility: C87075 986
state: Utah
city: Burlington
country: United States
facility: C87075 814
state: Vermont
city: Colchester
country: United States
facility: C87075 963
state: Vermont
city: Christiansburg
country: United States
facility: C87075 675
state: Virginia
city: Norfolk
country: United States
facility: C87075 691
state: Virginia
city: Richmond
country: United States
facility: C87075 446
state: Virginia
city: Virginia Beach
country: United States
facility: C87075 026
state: Virginia
city: Woodbridge
country: United States
facility: C87075 273
state: Virginia
city: Seattle
country: United States
facility: C87075 471
state: Washington
city: Tacoma
country: United States
facility: C87075 925
state: Washington
city: Green Bay
country: United States
facility: C87075 465
state: Wisconsin
city: Madison
country: United States
facility: C87075 116
state: Wisconsin
city: Milwaukee
country: United States
facility: C87075 070
state: Wisconsin
city: Milwaukee
country: United States
facility: C87075 281
state: Wisconsin
city: Milwaukee
country: United States
facility: C87075 389
state: Wisconsin
city: Milwaukee
country: United States
facility: C87075 578
state: Wisconsin
city: Oshkosh
country: United States
facility: C87075 093
state: Wisconsin
Study officials:
affiliation: 001 844 599 2273(UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: