Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Peter Higgins
Study ID
NCT01674413
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab 40 mg q 2 weeks, with placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38
  • Adalimumab PRN — DRUG
    160 mg/80 mg Adalimumab at Weeks 0 and 2, followed by 1 syringe SC placebo q 2 weeks (except at Weeks 12/14, 24/26, and 36/38), with * PRNLOADing of 160 mg/80 mg Adalimumab at Weeks 12/14, 24/26, or 36/38 if most recent FCP is ≥167 mcg/gram of stool, * Or, placebo loading of 4 syringes/2 syringes at Weeks 12/14, 24/26, and 36/38 if most recent FCP is \< 167 mcg/gram of stool.
  • Placebo — DRUG
    1 syringe of placebo SC q 2 weeks, with additional placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38 Weeks.

Study Details

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.

Key Dates

Start date
Oct 31, 2013
Status verified
May 2017
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo/Step-Down
    1 syringe of placebo SC q 2 weeks.
  • Active Comparator: PRNLOAD Arm
    160 mg/80 mg Adalimumab at Weeks 0 and 2, followed by 1 syringe SC placebo q 2 weeks (except at Weeks 12/14, 24/26, and 36/38)
  • Active Comparator: Maintenance Arm
    Adalimumab 40 mg q 2 weeks.

Primary Outcome Measure

Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms [ Time Frame: 48 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Health SystemAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Michigan Health System· Ann Arbor, MI

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