Calprotectin-Directed Humira� Maintenance Therapy (CADHUM)
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Adalimumab (Drug); Adalimumab (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Peter Higgins Official(s) and/or principal investigator(s): Peter D Higgins, MD, PhD, MSc, Principal Investigator, Affiliation: University of Michigan
Overall contact: Katy Patten, B.Sc., Phone: 734-615-4843, Email: pattenk@med.umich.edu
Summary
This is a study that invites adults with Crohn's disease and have been responding well to
Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance
medications in Crohn's disease, particularly when in remission. Patients want to know that
they truly need to take a medication, yet they don't want to have flares. The purpose of
this study is to see that if we monitor the patient, along with looking at changes in their
stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks,
or add as-needed dosing only, and keep them in remission.
Clinical Details
Official title: Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms
Secondary outcome: Percent Time in Remission MAINT vs. PRNLOADPercent Time in Remission MAINT vs. PBO Strict Biologic Remission Rates Subject acceptability Subject preference Equivalence of Percent Time in Remission Comparison of Average CDAI Comparison of average IBDQ Comparison of average FCP Comparison of average CRP Comparison of Rates of Hospitalization Comparison of Rates of Emergency Department visits Comparison of Rates of Physician visits Comparison of mg prednisone prescribed
Detailed description:
Patients frequently discontinue maintenance medications in Crohn's disease, particularly
when in remission. Patients want to know that they truly need to take a medication, yet
they don't want to have flares. As a biomarker, fecal calprotectin < 167 has a 100%
negative predictive value for flare within the next 12 weeks (Gisbert, 2009). Adalimumab
has low antigenicity, and can be safely stopped and restarted later with good clinical
effect (Colombel, 2007). Patients want intermittent therapy, if it can be delivered in a
timely fashion when pre-clinical inflammation starts, in order to avoid
clinically-significant flares. This study will combine monitoring for pre-clinical
inflammation with fecal calprotectin and as-needed dosing with Adalimumab to maintain
remission in patients who have obtained remission with Adalimumab. This will be compared to
two comparator arms: standard maintenance therapy and complete cessation of therapy
(Step-Down approach).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Men or women 18 years of age or older at the time of informed consent.
2. Crohn's disease confirmed by endoscopy with biopsies.
3. On maintenance Adalimumab at a dose of 40 mg SC q 2 weeks without concomitant
immunosuppressive therapy.
4. Must be in clinical remission (CDAI <150) at the baseline/randomization (Week 0)
visit and biologic remission (both CRP <0. 8 and FCP <167)at Week 0.
5. Prior medication for Crohn's disease may include one of the following and must have
been stopped with wash out periods: Methotrexate, Azathioprine, 6-Mercaptopurine,
Tacrolimus, Steroids.
6. Negative for TB, Hepatitis B-negative, and negative stool for Clostridium difficile.
Exclusion Criteria
1. Unable to consent for themselves.
2. Are prisoners, students or employees of the investigators, or mentally incapacitated.
3. Are unwilling to complete this 48 week study, provide stool samples throughout, or
unwilling to undergo multiple venipunctures.
4. Have a current infection with Clostridium difficile, clinically-significant
intestinal stricture, history of allergy, or adverse reaction, to Adalimumab, history
of sensitivity to latex.
5. Are currently using steroids or systemic immunomodulators (MTX, AZA, 6-MP, or
Tacrolimus), or have used another biologic medication in the past 12 weeks other than
Adalimumab, or have current or past use of Kineret® (Anakinra) or Tysabri®
(natalizumab).
6. Have received any live bacterial or viral vaccinations ≤ 12 weeks prior to Week 0 and
must not receive 12 months after study as well as BCG vaccination
7. Are known to have congestive heart failure.
8. Have a history of, or ongoing chronic or recurrent infectious disease, including but
not limited to chronic renal, chest infection (i. e. bronchiectasis) or urinary tract
infection (i. e. recurrent pyelonephritis) or open, draining, or infected skin wounds
or ulcers.
9. Have evidence of current clinically active and important infection.
10. Have or ever had a non-tuberculous mycobacterium infection or serious opportunistic
infection (i. e. cytomegalovirus, Pneumocystis carinii, aspergillosis).
11. Are known to be infected with HIV, Hepatitis B, or Hepatitis C.
12. Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine,
pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and
symptoms thereof.
13. Have a known history of lymphoproliferative disease including lymphoma. Have a
history of certain malignancies within five years of screening.
Locations and Contacts
Katy Patten, B.Sc., Phone: 734-615-4843, Email: pattenk@med.umich.edu
University of Michigan Health System, Ann Arbor, Michigan 48109, United States; Not yet recruiting Katy Patten, BSc, Phone: 734-615-4843, Email: pattenk@med.umich.edu Kay Sauder, BSc, Phone: 734-647-2564, Email: ksauder@umich.edu
Additional Information
Starting date: October 2013
Last updated: December 1, 2014
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