NCT01674413

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

August 16, 2012

Last Update Submit

May 23, 2017

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseCrohn'sCrohnsInflammatory Bowel DiseaseIBDHumiraAdalimumabAdalimumab injectionHigginsCalprotectinbiomarkersGastroenterologyUniversity of MichiganU of M

Outcome Measures

Primary Outcomes (1)

  • Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms

    Determine whether adding as-needed q 12 weeks Adalimumab re-loading (160 mg/80 mg) when FCP ≥167 mcg/gram of stool can improve the maintenance of remission in Crohn's disease patients who stop Adalimumab therapy (PRNLOAD Arm) compared to the placebo arm. Endpoint: Percent time in remission (q 4 week evaluation for 48 weeks).

    48 weeks

Secondary Outcomes (14)

  • Percent Time in Remission MAINT vs. PRNLOAD

    48 weeks

  • Percent Time in Remission MAINT vs. PBO

    48 weeks.

  • Strict Biologic Remission Rates

    48 weeks

  • Subject acceptability

    48 weeks

  • Subject preference

    48 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • Anti-Adalimumab antibodies

    0, 48 weeks

Study Arms (3)

Placebo/Step-Down

PLACEBO COMPARATOR

1 syringe of placebo SC q 2 weeks.

Drug: Placebo

PRNLOAD Arm

ACTIVE COMPARATOR

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)

Drug: Adalimumab PRN

Maintenance Arm

ACTIVE COMPARATOR

Adalimumab 40 mg q 2 weeks.

Drug: Adalimumab

Interventions

AdalimumabDRUG

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

Also known as: Humira
Maintenance Arm
Adalimumab PRNDRUG

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.

Also known as: Humira
PRNLOAD Arm
PlaceboDRUG

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.

Placebo/Step-Down

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women 18 years of age or older at the time of informed consent.
  • Crohn's disease confirmed by endoscopy with biopsies.
  • On maintenance Adalimumab at a dose of 40 mg SC q 2 weeks without concomitant immunosuppressive therapy.
  • 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.
  • 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.
  • Negative for TB, Hepatitis B-negative, and negative stool for Clostridium difficile.

You may not qualify if:

  • Unable to consent for themselves.
  • Are prisoners, students or employees of the investigators, or mentally incapacitated.
  • Are unwilling to complete this 48 week study, provide stool samples throughout, or unwilling to undergo multiple venipunctures.
  • Have a current infection with Clostridium difficile, clinically-significant intestinal stricture, history of allergy, or adverse reaction, to Adalimumab, history of sensitivity to latex.
  • 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).
  • 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
  • Are known to have congestive heart failure.
  • 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.
  • Have evidence of current clinically active and important infection.
  • Have or ever had a non-tuberculous mycobacterium infection or serious opportunistic infection (i.e. cytomegalovirus, Pneumocystis carinii, aspergillosis).
  • Are known to be infected with HIV, Hepatitis B, or Hepatitis C.
  • Have severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
  • Have a known history of lymphoproliferative disease including lymphoma. Have a history of certain malignancies within five years of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Peter D Higgins, MD, PhD, MSc

    University of Michigan

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D., MSc. Assistant Professor of Medicine

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 28, 2012

Study Start

October 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

no data collected

Locations

US(1)