← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 8, 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects who achieved remission

Secondary outcome measures

Proportion of steroid free subjects

Proportion of subjects who achieved clinical response

Rates of complications

+2 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

956 Previous Clinical Trials

501,150 Total Patients Enrolled

waqqas.afifLead Sponsor

Waqqas Afif, MD, FRCPCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Media Library

Adalimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03261102 — N/A

Inflammatory Bowel Disease Research Study Groups: Active optimization, Standard clinical care

Inflammatory Bowel Disease Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT03261102 — N/A

Adalimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03261102 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this research project?

"Affirmative. Clinicaltrials.gov data shows that this research endeavor, which was first introduced on January 17th 2017, is actively seeking patients. A total of 200 volunteers are needed from 3 distinct healthcare centres."

Answered by AI

In what scenarios is Active optimization employed therapeutically?

"Active optimization is primarily implemented to address ankylosing spondylitis, although it can also be a viable solution for rheumatoid arthritis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis."

Answered by AI

Has Active optimization been the subject of prior research?

"Firstly observed by researchers at University of Nebraska Medical Center in 2007, active optimization has become the subject of 288 clinical trials. Of these experiments, 45 are presently recruiting participants with a high concentration of them located in Montréal, Quebec."

Answered by AI

Is there currently an opportunity for people to become part of this scientific endeavor?

"Yes, according to clinicaltrials.gov this research project is actively enrolling participants. This trial was first published on the 17th of January 2017 and its details have been most recently updated on March 31st 2023. 200 patients are sought from 3 medical centres for consideration in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TDM Guided Early Optimization of ADAL in Crohn's Disease

waqqas.afif 2017. "TDM Guided Early Optimization of ADAL in Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03261102.

All > Inflammatory Bowel Disease > Crohns Disease