Calprotectin-Directed Humira® Maintenance Therapy (CADHUM) (CADHUM)
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ClinicalTrials.gov Identifier: NCT01674413 |
Recruitment Status
:
Withdrawn
(Unable to recruit; all patients interested simply wanted to stop medication)
First Posted
: August 28, 2012
Last Update Posted
: May 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: Adalimumab Drug: Adalimumab PRN Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's Disease |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo/Step-Down
1 syringe of placebo SC q 2 weeks.
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Drug: Placebo
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.
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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)
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Drug: Adalimumab PRN
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
Other Name: Humira
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Active Comparator: Maintenance Arm
Adalimumab 40 mg q 2 weeks.
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Drug: Adalimumab
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
Other Name: Humira
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- Percent Time in Remission (PTIR) in PRNLOAD vs. Placebo arms [ Time Frame: 48 weeks ]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).
- Percent Time in Remission MAINT vs. PRNLOAD [ Time Frame: 48 weeks ]Compare the percent of monitoring visits in which the subject is in remission in each arm between the MAINT and PRNLOAD arms.
- Percent Time in Remission MAINT vs. PBO [ Time Frame: 48 weeks. ]Compare the percent of monitoring visits in which the subject is in remission in each arm between the MAINT and PBO arms.
- Strict Biologic Remission Rates [ Time Frame: 48 weeks ]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
- Subject acceptability [ Time Frame: 48 weeks ]Measure subject acceptability of repeated stool sampling.
- Subject preference [ Time Frame: 48 weeks ]Measure subject preference for the MAINT versus PRNLOAD regimen.
- Equivalence of Percent Time in Remission [ Time Frame: 48 weeks ]Compare percent time in remission (CDAI <150) over 48 weeks, evaluation every 4 weeks across 3 arms (chi square test).
- Comparison of Average CDAI [ Time Frame: 48 weeks ]Compare average CDAI over 48 weeks, evaluation every 4 weeks across 3 arms (ANOVA).
- Comparison of average IBDQ [ Time Frame: 48 weeks ]Compare average IBDQ over 48 weeks, evaluation every 4 weeks across 3 arms (ANOVA).
- Comparison of average FCP [ Time Frame: 48 weeks ]Compare average FCP over 48 weeks, evaluation every 12 weeks across 3 arms (ANOVA).
- Comparison of average CRP [ Time Frame: 48 weeks ]Compare average CRP over 48 weeks, evaluation every 12 weeks across 3 arms (ANOVA).
- Comparison of Rates of Hospitalization [ Time Frame: 48 Weeks ]Comparison of Rates of Hospitalization across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).
- Comparison of Rates of Emergency Department visits [ Time Frame: 48 Weeks ]Comparison of Rates of Emergency Department visits across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).
- Comparison of Rates of Physician visits [ Time Frame: 48 Weeks ]Comparison of Rates of Physician visits across all 3 arms - hospital admissions per patient over 48 weeks (ANOVA).
- Comparison of mg prednisone prescribed [ Time Frame: 48 Weeks ]Comparison of average milligrams of prednisone prescribed across all 3 arms - over 48 weeks (ANOVA).
- Anti-Adalimumab antibodies [ Time Frame: 0, 48 weeks ]Measure anti-Adalimumab antibody titers in patients at week 0 and 48 weeks (or exit visit). Compare average titers across 3 arms (ANOVA)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674413
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Peter D Higgins, MD, PhD, MSc | University of Michigan |
Responsible Party: | Peter Higgins, M.D., Ph.D., MSc. Assistant Professor of Medicine, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01674413 History of Changes |
Other Study ID Numbers: |
Abbott IMM 10-0105 Abbott IMM 10-0105 ( Other Grant/Funding Number: Abbott ) |
First Posted: | August 28, 2012 Key Record Dates |
Last Update Posted: | May 24, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | no data collected |
Keywords provided by Peter Higgins, University of Michigan:
Crohn's Disease Crohn's Crohns Inflammatory Bowel Disease IBD Humira Adalimumab |
Adalimumab injection Higgins Calprotectin biomarkers Gastroenterology University of Michigan U of M |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |