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Does Clinical Response Correlate With Serum Certolizumab Levels? | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Does Clinical Response Correlate With Serum Certolizumab Levels?

Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO)

NCT02597829•Shafran Gastroenterology Center

View on ClinicalTrials.gov

Summary

A prospective open label trial of adult patients with active Crohn's disease to determine if plasma concentrations of certolizumab pegol correlate to mucosal healing.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females ≥ 18 and ≤ 70 years of age.
•2. Diagnosis of colonic, ileocolonic, or ileal Crohn's disease for ≥ 3 months confirmed by radiography, histology, and/or endoscopy at any time in the past.
•3. Moderately to severely active Crohn's disease as defined by a Harvey Bradshaw
•Index (HBI) ≥ 8 at baseline AND at least one of the following:
•* Abnormal CRP at screening (\> Upper Limit of Normal \[ULN\] accepted lab assay)
•* Elevated fecal calprotectin at screening (\> ULN accepted lab assay)
•* Endoscopic evidence (colonoscopy or small bowel video capsule endoscopy) of active Crohn's ulcerations within 3 months of baseline or during screening
•4. Taking a stable dose of corticosteroids (oral or anorectal) ≤ 40 mg/day, or equivalent, for at least 2 weeks prior to baseline.
•5. Taking a stable dose of 5-ASA, antibiotics, anti-diarrheals, analgesics, and/or probiotics for at least 4 weeks prior to baseline.
•6. Taking a stable dose of immunosuppressants for at least 8 weeks prior to baseline.
+15 more criteria

Exclusion Criteria

•1. Any and all contraindications to the use of certolizumab pegol including: active or latent TB, active viral infection or chronic recurrent infections, evidence of dysplasia or history of malignancy, congestive heart failure (CHF), demyelinating disease and cytopenia.
•2. Subject who previously received treatment with certolizumab pegol or previously participated in a certolizumab pegol study.
•3. Has complications of Crohn's disease such as symptomatic strictures or stenoses, short bowel syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the HBI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with certolizumab pegol.
•4. Subject has had surgical bowel resection(s) within 6 months or any other intra- abdominal surgery within 3 months prior to baseline.
•5. Subject with an ostomy or ileoanal pouch.
•6. Subject has received anti-TNF agents \< 8 weeks prior to baseline.
•7. Subject has received other immunomodulatory biologic agents, \< 8 weeks or within 5 half-lives of agent prior to baseline, whichever is longer
•8. Subject is known to be infected with HIV, Hepatitis B or Hepatitis C
•9. Subject with positive Clostridium difficile (C. difficile) toxin stool assay during the Screening period.
•10. Subject has severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms
+4 more criteria

Locations (1)

Shafran Gastroenterology Center

Winter Park, Florida, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

May 1, 2018

Completion Date

October 1, 2018

Last Updated

November 5, 2015

Enrollment

ESTIMATED participants

Conditions

Crohn's Disease

Interventions

Certolizumab Pegol

DRUG

Contacts

Kara Fitch, R.N.

CONTACT

(407) 629-8121 kara.fitch@gmail.com

Renee DePanicis, R.N.

CONTACT

(407) 629-8121 rmdrn74@yahoo.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Does Clinical Response Correlate With Serum Certolizumab Levels?

Inclusion Criteria

Exclusion Criteria

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