Does Clinical Response Correlate With Serum Certolizumab Levels?

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.