Does Clinical Response Correlate With Serum Certolizumab Levels?
APOLLO
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedNovember 5, 2015
November 1, 2015
2.5 years
October 27, 2015
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects who achieve endoscopic improvement.
20 Weeks
Secondary Outcomes (2)
Proportion of subjects who achieve clinical response.
20 Weeks
Proportion of subjects who achieve clinical remission.
20 Weeks
Study Arms (1)
Open Label Certolizumab Pegol
OTHERActive Treatment
Interventions
Eligibility Criteria
You may qualify if:
- Males and females ≥ 18 and ≤ 70 years of age.
- 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.
- 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
- Taking a stable dose of corticosteroids (oral or anorectal) ≤ 40 mg/day, or equivalent, for at least 2 weeks prior to baseline.
- Taking a stable dose of 5-ASA, antibiotics, anti-diarrheals, analgesics, and/or probiotics for at least 4 weeks prior to baseline.
- Taking a stable dose of immunosuppressants for at least 8 weeks prior to baseline.
- 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
- +10 more criteria
You may not qualify if:
- 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.
- Subject who previously received treatment with certolizumab pegol or previously participated in a certolizumab pegol study.
- 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.
- Subject has had surgical bowel resection(s) within 6 months or any other intra- abdominal surgery within 3 months prior to baseline.
- Subject with an ostomy or ileoanal pouch.
- Subject has received anti-TNF agents \< 8 weeks prior to baseline.
- Subject has received other immunomodulatory biologic agents, \< 8 weeks or within 5 half-lives of agent prior to baseline, whichever is longer
- Subject is known to be infected with HIV, Hepatitis B or Hepatitis C
- Subject with positive Clostridium difficile (C. difficile) toxin stool assay during the Screening period.
- Subject has severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms
- Has a known history or lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive or possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- History of clinically significant drug or alcohol abuse in the 12 months prior to baseline.
- 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.
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shafran Gastroenterology Centerlead
- UCB Pharmacollaborator
Study Sites (1)
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ira Shafran, M.D.
Shafran Gastroenterology Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
November 5, 2015
Study Start
November 1, 2015
Primary Completion
May 1, 2018
Study Completion
October 1, 2018
Last Updated
November 5, 2015
Record last verified: 2015-11