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Does Clinical Response Correlate With Serum Certolizumab Levels? (APOLLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02597829
Recruitment Status : Unknown
Verified November 2015 by Shafran Gastroenterology Center.
Recruitment status was:  Not yet recruiting
First Posted : November 5, 2015
Last Update Posted : November 5, 2015
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Shafran Gastroenterology Center

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Certolizumab Pegol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO)
Study Start Date : November 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Open Label Certolizumab Pegol
Active Treatment
Drug: Certolizumab Pegol
Subcutaneous Injection
Other Name: Cimzia




Primary Outcome Measures :
  1. Proportion of subjects who achieve endoscopic improvement. [ Time Frame: 20 Weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve clinical response. [ Time Frame: 20 Weeks ]
  2. Proportion of subjects who achieve clinical remission. [ Time Frame: 20 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597829


Contacts
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Contact: Kara Fitch, R.N. (407) 629-8121 kara.fitch@gmail.com
Contact: Renee DePanicis, R.N. (407) 629-8121 rmdrn74@yahoo.com

Locations
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United States, Florida
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
Contact: Renee DePanicis, R.N.    407-629-8121    rmdrn74@yahoo.com   
Contact: Kara Fitch, R.N.    (407) 629-8121    kara.fitch@gmail.com   
Principal Investigator: Ira Shafran, M.D.         
Sub-Investigator: Patricia Burgunder, A.R.N.P.         
Sponsors and Collaborators
Shafran Gastroenterology Center
UCB Pharma
Investigators
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Principal Investigator: Ira Shafran, M.D. Shafran Gastroenterology Center

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Responsible Party: Shafran Gastroenterology Center
ClinicalTrials.gov Identifier: NCT02597829    
Other Study ID Numbers: ShafranGC
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015
Keywords provided by Shafran Gastroenterology Center:
Inflammatory Bowel Disease
Mucosal Healing
Certolizumab pegol
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents