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Monoclonal Antibodies

Dose-Adjusted Adalimumab for Crohn's Disease

N/A

Recruiting

Led By Waqqas Afif, MD, FRCPC

Research Sponsored by waqqas.afif

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation)

Age 18 or older

Must not have

Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease

History of active HIV, hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 8, 12

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial looks at if adjusting the dose of a drug used to treat Crohn's can improve outcomes.

Who is the study for?

This trial is for adults over 18 with Crohn's Disease, who are about to start treatment with Adalimumab. They should have active disease shown by a Harvey Bradshaw Index greater than 5 and high levels of CRP or fecal calprotectin. People can't join if they have severe other diseases, certain infections like HIV or hepatitis B/C, specific intestinal surgeries, are pregnant, or have used Adalimumab before.

What is being tested?

The study tests how monitoring drug levels early on and adjusting doses affects the outcome in Crohn's patients taking Adalimumab. It aims to see if this approach leads to better control of the disease symptoms.

What are the potential side effects?

Adalimumab may cause injection site reactions, increased risk of infections due to immune system suppression, headaches, rash and gastrointestinal symptoms. Serious side effects could include allergic reactions and autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Crohn's disease through various tests.

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I am 18 years old or older.

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My Crohn's disease is active, shown by high HBI and CRP or FCP levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart, lung, liver, kidney, nerve, or joint diseases.

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I have an active HIV, hepatitis B, or C infection.

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I have an ileostomy, colostomy, or severe perianal disease.

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I have been treated with ADAL before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 8, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 8, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects who achieved remission

Secondary study objectives

Proportion of steroid free subjects

Proportion of subjects who achieved clinical response

Rates of complications

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Active optimizationActive Control1 Intervention

Same as Standard clinical care Arm, except: * If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week * If ADAL trough \>15 μg/ml, no dose escalation and continued standard of care dosing

Group II: Standard clinical careActive Control1 Intervention

Adalimumab induction as per standard clinical care: * Week 0: 160 mg SC * Week 2: 80 mg SC * Followed by 40 mg SC every 2 weeks' maintenance therapy

0 / 7Eligibility criteria met