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Crohn's DiseasePhase 3CADHUMNCT01674413

Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)

A Phase 3 study testing Adalimumab and Adalimumab PRN in people with Crohn's Disease, run by Peter Higgins at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Adalimumab and Adalimumab PRN
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2013to Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's Disease

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.

Read the 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).

Conditions
Crohn's Disease
Being tested
Adalimumab, Adalimumab PRN, Placebo
Keywords
Crohn's Disease, Crohn's, Crohns, Inflammatory Bowel Disease, IBD, Humira, Adalimumab, Adalimumab injection, Higgins, Calprotectin, biomarkers, Gastroenterology, University of Michigan, U of M
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

    Also called Humira

    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 PRNDrug

    Also called Humira

    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.

  • 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.

Study groups in NCT01674413
Study groupRoleWhat they receive
Placebo/Step-DownPlacebo comparator1 syringe of placebo SC q 2 weeks.
Receives: Drug: Placebo
PRNLOAD ArmActive comparator160 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)
Receives: Drug: Adalimumab PRN
Maintenance ArmActive comparatorAdalimumab 40 mg q 2 weeks.
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 48 weeks

Secondary outcomes (14)

  1. Percent Time in Remission MAINT vs. PRNLOAD

    Compare the percent of monitoring visits in which the subject is in remission in each arm between the MAINT and PRNLOAD arms.

    Measured: 48 weeks

  2. Percent Time in Remission MAINT vs. PBO

    Compare the percent of monitoring visits in which the subject is in remission in each arm between the MAINT and PBO arms.

    Measured: 48 weeks.

  3. Strict Biologic Remission Rates

    Percent of visits with strict biologic remission (FCP <50 and CRP <0.5) with 3 comparisons: PRNLOAD vs. PBO, MAINT vs. PRNLOAD, MAINT vs. PBO

    Measured: 48 weeks

  4. Subject acceptability

    Measure subject acceptability of repeated stool sampling.

    Measured: 48 weeks

  5. Subject preference

    Measure subject preference for the MAINT versus PRNLOAD regimen.

    Measured: 48 weeks

  6. Equivalence of Percent Time in Remission

    Compare percent time in remission (CDAI <150) over 48 weeks, evaluation every 4 weeks across 3 arms (chi square test).

    Measured: 48 weeks

  7. Comparison of Average CDAI

    Compare average CDAI over 48 weeks, evaluation every 4 weeks across 3 arms (ANOVA).

    Measured: 48 weeks

  8. Comparison of average IBDQ

    Compare average IBDQ over 48 weeks, evaluation every 4 weeks across 3 arms (ANOVA).

    Measured: 48 weeks

  9. Comparison of average FCP

    Compare average FCP over 48 weeks, evaluation every 12 weeks across 3 arms (ANOVA).

    Measured: 48 weeks

  10. Comparison of average CRP

    Compare average CRP over 48 weeks, evaluation every 12 weeks across 3 arms (ANOVA).

    Measured: 48 weeks

  11. Comparison of Rates of Hospitalization

    Comparison of Rates of Hospitalization across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).

    Measured: 48 Weeks

  12. Comparison of Rates of Emergency Department visits

    Comparison of Rates of Emergency Department visits across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).

    Measured: 48 Weeks

  13. Comparison of Rates of Physician visits

    Comparison of Rates of Physician visits across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).

    Measured: 48 Weeks

  14. Comparison of mg prednisone prescribed

    Comparison of average milligrams of prednisone prescribed across all 3 arms - over 48 weeks (ANOVA).

    Measured: 48 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startOct 2013
  3. Primary completionMar 2016
  4. Study completionMar 2016

Why it stopped: Unable to recruit; all patients interested simply wanted to stop medication

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674413
Sponsor's protocol ID
Abbott IMM 10-0105
Other IDs
Abbott IMM 10-0105
Acronym
CADHUM
Status last verified
May 2017
First submitted
16 Aug 2012
Last updated
24 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: no data collected

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and Adalimumab PRN in people with Crohn's Disease, run by Peter Higgins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01674413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.

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