Does Clinical Response Correlate With Serum Certolizumab Levels?

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02597829
• Date of registration: 27/10/2015
• Prospective Registration: Yes
• Primary sponsor: Shafran Gastroenterology Center
• Public title: Does Clinical Response Correlate With Serum Certolizumab Levels? APOLLO
• Scientific title: Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO)
• Date of first enrolment: November 2015
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02597829
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Kara Fitch, R.N.

• Name: Renee DePanicis, R.N.

• Name: Ira Shafran, M.D.
• Affiliation: Shafran Gastroenterology Center

Key inclusion & exclusion criteria

Subject 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.

7. Have screening laboratory test results within the following parameters:

- Hemoglobin = 8.5 g/dL

- WBC count = 3.5 x 103 µL

- Neutrophils = 1.5 x 103 µL

- Platelets = 100 x 103 µL

- Serum creatinine < 1.7 mg/dL

- AST and ALT concentrations must be within 2 times the ULN range for the
laboratory conducting the test

8. Subject has a negative TB Screening Assessment (including a PPD test) and negative
chest x-ray (posterior-anterior or PA and lateral view) within 2 months prior to
screening.

9. If female, subject is either not of childbearing potential, defined as postmenopausal
(> 45 years of age with amenorrhea for at least 18 months) or surgically sterile
(bilateral tubal ligation, bilateral oophorectomy, hysterectomy or otherwise
incapable of pregnancy) or is of childbearing potential and is practicing on of the
following methods of birth control:

- Implants, injectables, some intrauterine devices (IUDs), intrauterine hormone
releasing system (IUS), hormonal prescription oral contraceptives, contraceptive
patch, or double barrier method

- Male partner sterilization

- Not heterosexually active

10. Negative serum pregnancy test at screening and a negative urine pregnancy test at
baseline.

11. If male, not surgically sterile, and heterosexually active with a woman of child
bearing potential, subject must agree to use a double barrier method of birth control
and not donate sperm during the study and for 12 weeks after receiving study agent.

12. Subject must be able and willing to give written informed consent and to comply with
the requirements of the study protocol.

Subject 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

11. Has a known history or lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive or possible lymphoproliferative disease, such as lymphadenopathy
or splenomegaly

12. History of clinically significant drug or alcohol abuse in the 12 months prior to
baseline.

13. Female subjects who are pregnant, breast-feeding, or planning to become pregnant or a
man who plans to father a child while enrolled in this study or within 20 weeks after
the last dose of study agent.

14. Subject is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Certolizumab Pegol

Primary Outcome(s)

Proportion of subjects who achieve endoscopic improvement. [Time Frame: 20 Weeks]

Secondary Outcome(s)

Proportion of subjects who achieve clinical remission. [Time Frame: 20 Weeks]

Proportion of subjects who achieve clinical response. [Time Frame: 20 Weeks]

Secondary ID(s)

ShafranGC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UCB Pharma