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NCT Number: NCT03261102

TDM Guided Early Optimization of ADAL in Crohn's Disease

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn Disease Digestive System Diseases Drug Monitoring Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary Medical Center (UCMC), Calgary, Alberta, Canada

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About this study

This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older.
  • Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
  • Active disease based on Harvey Bradshaw Index (HBI >5) and elevated C-reactive protein (CRP) (>normal reference range for local laboratory) OR fecal calprotectin (FCP) (>250 µg/g)
  • Due to commence treatment with ADAL.

Exclusion criteria

  • Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
  • History of active HIV, hepatitis B or C infection,
  • Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
  • Pregnancy
  • Prior exposure to ADAL

Treatment and study plan

Adalimumab

Biological

Other names: Humira

Primary outcomes

  1. Proportion of subjects who achieved remission

    Time frame: Week 12

    Clinical remission will be scored by a Harvey-Bradshaw Index < 5 AND Biochemical remission will be scored by C-reactive protein < 5 mg/l OR Fecal calprotectin <250 μg/g (combination endpoint)

Secondary outcomes

  1. Proportion of subjects who achieved clinical response

    Time frame: From Week 0 to Week 12

    Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin

  2. Therapeutic drug monitoring

    Time frame: At Week 8, 12

    Adalimumab drug concentration at week 8 and 12 AND proportion of subjects with antibody to Adalimumab at Week 8 and 12 on the rate i. Clinical response/remission (HBI<5) ii. Biochemical response/remission (CRP within normal reference range) iii. Endoscopic response (SES-CD reduction of ≥50% from baseline) / remission (SES-CD ≤3)

  3. Proportion of steroid free subjects

    Time frame: At Week 12

    Steroid free defined as patients being steroid free at Week 12

  4. Subjects well-being

    Time frame: From Week 0 to Week 12

    Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)

  5. Rates of complications

    Time frame: 12 weeks

    Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.

Sponsors and collaborators

Lead sponsor

waqqas.afif

Other

Collaborators

  • AbbVie

Registry information

Official study title

Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2017
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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