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Crohn's DiseaseSECURENCT00844285

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

An observational study of Crohn's Disease, run by UCB BIOSCIENCES, Inc. at 197 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Cimzia
Type of treatment
Injection or infusion
How many people
3,072 participants
Where
197 sitesUnited States
Study dates
30 Jan 2009to 21 Aug 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • See inclusion criteria

Trial locations and contacts

197 sites in 1 country.

197 sites in 1 country

United States197 sites

  • C87075 947

    Allentown, Pennsylvania, 18104

  • C87075 639

    Altamonte Springs, Florida, 32701

  • C87075 869

    Ann Arbor, Michigan, 48109

  • C87075 235

    Annapolis, Maryland, 21041

  • C87075 040

    Annapolis, Maryland, 21401

  • C87075 278

    Arlington Heights, Illinois, 60005

  • C87075 051

    Asheville, North Carolina, 28801

  • C87075 399

    Atlanta, Georgia, 30322

  • C87075 288

    Atlanta, Georgia, 30342

  • C87075 849

    Atlanta, Georgia, 30342

  • C87075 272

    Austin, Texas, 78705

  • C87075 200

    Austin, Texas, 78758

  • C87075 181

    Baltimore, Maryland, 21201

  • C87075 953

    Baltimore, Maryland, 21202

  • C87075 072

    Baton Rouge, Louisiana, 70808

  • C87075 059

    Beverly Hills, California, 90211

  • C87075 931

    Birmingham, Alabama, 35209

  • C87075 198

    Birmingham, Alabama, 35233

  • C87075 955

    Bismarck, North Dakota, 58501

  • C87075 049

    Boca Raton, Florida, 33428

  • C87075 871

    Boca Raton, Florida, 33486

  • C87075 229

    Boise, Idaho, 83712

  • C87075 091

    Boston, Massachusetts, 02111

  • C87075 567

    Boston, Massachusetts, 02215

  • C87075 946

    Boulder, Colorado, 80304

  • C87075 540

    Bridgeton, Missouri, 63044

  • C87075 024

    Brooklyn, New York, 11235

  • C87075 814

    Burlington, Vermont, 05401

  • C87075 239

    Canton, Ohio, 44718

  • C87075 807

    Canton, Ohio, 44718

  • C87075 636

    Chapel Hill, North Carolina, 27599

  • C87075 176

    Charleston, South Carolina, 29425

  • C87075 185

    Charlotte, North Carolina, 28210

  • C87075 965

    Charlotte, North Carolina, 28211

  • C87075 005

    Cherry Hill, New Jersey, 08053

  • C87075 260

    Chesterfield, Michigan, 48047

  • C87075 418

    Chicago, Illinois, 60612

  • C87075 168

    Chicago, Illinois, 60637

  • C87075 675

    Christiansburg, Virginia, 24073

  • C87075 042

    Cincinnati, Ohio, 45249

  • C87075 016

    Cincinnati, Ohio, 45267

  • C87075 462

    Cleveland, Ohio, 44195

  • C87075 343

    Clive, Iowa, 50325

  • C87075 963

    Colchester, Vermont, 05401

  • C87075 163

    Columbia, Missouri, 65201

  • C87075 813

    Columbia, South Carolina, 29169

  • C87075 945

    Concord, North Carolina, 28025

  • C87075 232

    Covington, Georgia, 30014

  • C87075 357

    Cumming, Georgia, 30041

  • C87075 941

    Dallas, Texas, 75230

  • C87075 628

    Dallas, Texas, 75231

  • C87075 336

    Decatur, Georgia, 30032

  • C87075 113

    Decatur, Georgia, 30033

  • C87075 988

    Decatur, Georgia, 30033

  • C87075 705

    Egg Harbor, New Jersey, 08234

  • C87075 580

    Encino, California, 91436

  • C87075 858

    Evanston, Illinois, 60201

  • C87075 973

    Fayetteville, North Carolina, 28304

  • C87075 362

    Flushing, New York, 11355

  • C87075 088

    Fort Sam Houston, Texas, 78234

  • C87075 226

    Fort Worth, Texas, 76104

  • C87075 021

    Fountain Valley, California, 92708

  • C87075 299

    Franklin, Tennessee, 37067

  • C87075 002

    Gainesville, Florida, 32610

  • C87075 413

    Great Neck, New York, 11021

  • C87075 517

    Great Neck, New York, 11042

  • C87075 465

    Green Bay, Wisconsin, 54307

  • C87075 527

    Greenville, North Carolina, 27834

  • C87075 087

    Hamden, Connecticut, 06518

  • C87075 214

    Hammond, Louisiana, 70403

  • C87075 077

    Hartford, Connecticut, 06106

  • C87075 241

    Hermitage, Pennsylvania, 16148

  • C87075 262

    Hermitage, Tennessee, 37076

  • C87075 759

    Hialeah, Florida, 33016

  • C87075 208

    Hoffman Estates, Illinois, 60169

  • C87075 893

    Hollywood, Florida

  • C87075 237

    Houston, Texas, 77030

  • C87075 419

    Houston, Texas, 77030

  • C87075 726

    Houston, Texas, 77030

  • C87075 286

    Huntsville, Alabama, 35802

  • C87075 245

    Idaho Falls, Idaho, 83404

  • C87075 151

    Indianapolis, Indiana, 46202

  • C87075 124

    Indianapolis, Indiana, 46237

  • C87075 757

    Jackson, Tennessee, 38308

  • C87075 321

    Jericho, New York, 11753

  • C87075 698

    Johns Creek, Georgia, 30342

  • C87075 195

    Kalamazoo, Michigan, 49048

  • C87075 127

    Kinston, North Carolina, 28501

  • C87075 224

    Knoxville, Tennessee, 37934

  • C87075 261

    La Jolla, California, 92037

  • C87075 541

    Lake Success, New York, 11042

  • C87075 143

    Lakeland, Florida, 33805

  • C87075 970

    Largo, Florida, 33777

  • C87075 937

    Las Vegas, Nevada, 89109

  • C87075 030

    Lauderdale Lakes, Florida, 33319

  • C87075 083

    Lawrenceville, Georgia, 30045

  • C87075 740

    Lebanon, New Hampshire, 03756

  • C87075 776

    Lee's Summit, Missouri, 64064

  • C87075 204

    Lexington, Kentucky, 40536

  • C87075 314

    Lima, Ohio, 45806

  • C87075 491

    Lonetree, Colorado, 80124

  • C87075 220

    Los Angeles, California, 90027

  • C87075 067

    Macon, Georgia, 31201

  • C87075 897

    Macon, Georgia, 31210

  • C87075 116

    Madison, Wisconsin, 53792

  • C87075 009

    Maitland, Florida, 32751

  • C87075 460

    Malvern, Pennsylvania, 19301

  • C87075 488

    Marietta, Georgia, 30067

  • C87075 930

    Marlton, New Jersey, 08053

  • C87075 610

    Mays Landing, New Jersey, 08330

  • C87075 929

    Mentor, Ohio, 44060

  • C87075 037

    Meridian, Idaho, 83702

  • C87075 108

    Metairie, Louisiana, 70006

  • C87075 305

    Mexico, Missouri, 65256

  • C87075 003

    Miami, Florida, 33136

  • C87075 004

    Miami, Florida, 33156

  • C87075 102

    Miami, Florida, 33156

  • C87075 420

    Miami, Florida, 33156

  • C87075 070

    Milwaukee, Wisconsin, 53209

  • C87075 281

    Milwaukee, Wisconsin, 53215

  • C87075 389

    Milwaukee, Wisconsin, 53226

  • C87075 578

    Milwaukee, Wisconsin, 53226

  • C87075 032

    Montgomery, Alabama, 36116

  • C87075 034

    Naples, Florida, 34102

  • C87075 323

    Nashua, New Hampshire, 03060

  • C87075 390

    Nashville, Tennessee, 37205

  • C87075 894

    Nashville, Tennessee, 37232

  • C87075 926

    New Bern, North Carolina, 28562

  • C87075 997

    New Orleans, Louisiana, 70121

  • C87075 118

    New York, New York, 10021

  • C87075 712

    New York, New York, 10021

  • C87075 494

    New York, New York, 10028

  • C87075 018

    New York, New York, 10032

  • C87075 395

    Newton, Massachusetts, 02114

  • C87075 691

    Norfolk, Virginia, 23502

  • C87075 939

    North Adams, Massachusetts, 01247

  • C87075 574

    North Little Rock, Arkansas, 72117

  • C87075 349

    Novi, Michigan, 48377

  • C87075 368

    Oak Lawn, Illinois, 60453

  • C87075 370

    Oakbrook Terrace, Illinois, 60181

  • C87075 867

    Ocean Springs, Mississippi, 39564

  • C87075 728

    Oceanside, California, 92056

  • C87075 031

    Orlando, Florida, 32803

  • C87075 487

    Orlando, Florida, 32803

  • C87075 935

    Orlando, Florida, 32819

  • C87075 093

    Oshkosh, Wisconsin, 54904

  • C87075 074

    Palm Coast, Florida, 32164

  • C87075 571

    Palm Springs, California, 92262

  • C87075 312

    Pasadena, Texas, 77505

  • C87075 166

    Philadelphia, Pennsylvania, 19104

  • C87075 086

    Pittsburgh, Pennsylvania, 15213

  • C87075 215

    Plymouth, Minnesota, 55446

  • C87075 213

    Portland, Oregon, 97225

  • C87075 159

    Poughkeepsie, New York, 12601

  • C87075 446

    Richmond, Virginia, 23298

  • C87075 161

    Ridgewood, New Jersey, 07450

  • C87075 501

    Rochester, Minnesota, 55905

  • C87075 300

    Rochester, New York, 14621

  • C87075 779

    Rocky Mount, North Carolina, 27804

  • C87075 986

    Salt Lake City, Utah, 84132

  • C87075 657

    San Antonio, Texas, 78229

  • C87075 923

    San Antonio, Texas, 78258

  • C87075 485

    San Carlos, California, 94070

  • C87075 183

    Sarasota, Florida, 34239

  • C87075 253

    Scottsdale, Arizona, 85260

  • C87075 471

    Seattle, Washington, 98195

  • C87075 987

    Shreveport, Louisiana, 71103

  • C87075 922

    Sioux Falls, South Dakota, 57108

  • C87075 279

    Southlake, Texas, 76051

  • C87075 085

    St Louis, Missouri, 63117

  • C87075 835

    St Louis, Missouri, 63141

  • C87075 884

    Stony Brook, New York, 11794

  • C87075 925

    Tacoma, Washington, 98405

  • C87075 144

    Tampa, Florida, 33626

  • C87075 366

    Temple, Texas, 76508

  • C87075 046

    Titusville, Florida, 32796

  • C87075 027

    Torrance, California, 90505

  • C87075 097

    Torrington, Connecticut, 06790

  • C87075 591

    Towson, Maryland, 21204

  • C87075 579

    Troy, Michigan, 48098

  • C87075 307

    Tucson, Arizona, 85710

  • C87075 377

    Tucson, Arizona, 85724

  • C87075 777

    Tulsa, Oklahoma, 74104

  • C87075 172

    Tulsa, Oklahoma, 74135

  • C87075 539

    Tyler, Texas, 75701

  • C87075 596

    Union City, Tennessee, 38261

  • C87075 271

    Vero Beach, Florida, 32960

  • C87075 026

    Virginia Beach, Virginia, 23454

  • C87075 280

    Weston, Florida, 33331

  • C87075 932

    Wilmington, North Carolina, 28401

  • C87075 729

    Winter Park, Florida, 32789

  • C87075 273

    Woodbridge, Virginia, 22192

  • C87075 165

    Woodbury, New Jersey, 08096

  • C87075 373

    Wyandotte, Michigan, 48192

  • C87075 167

    Wyoming, Michigan, 49519

  • C87075 843

    Wyoming, Michigan, 49519

  • C87075 829

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

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.

Read the 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.

Conditions
Crohn's Disease
Being tested
Cimzia
Keywords
Certolizumab Pegol, Cimzia ®, Crohn's Disease
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CimziaDrug

    The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.

Study groups in NCT00844285
Study groupRoleWhat they receive
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.
Receives: Drug: Cimzia
Comparison cohortPatient 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline up to 10 years

  2. 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.

    Measured: Baseline up to 10 years

Secondary outcomes (4)

  1. 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.

    Measured: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline

  2. 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.

    Measured: 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

  3. 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.

    Measured: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline

  4. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2009 (estimated)
  2. Study start30 Jan 2009
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,072 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00844285
Sponsor's protocol ID
C87075
Acronym
SECURE
Status last verified
Apr 2023
First submitted
13 Feb 2009
Last updated
6 May 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39895830

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by UCB BIOSCIENCES, Inc. at 197 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) (time frame: Baseline up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00844285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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