Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02148718) enrolled 86 people, all of whom received the medication adalimumab. The trial was set up to look at how participants with Crohn's disease responded to this treatment over time, using a scoring tool called the Harvey-Bradshaw Index (HBI) — a questionnaire that captures things like general wellbeing, abdominal pain, and the number of loose stools per day. Of the 86 people who started the trial, 55 completed it and 31 did not. The main thing the trial was measuring was the proportion of participants whose HBI score dropped by at least 3 points by Day 4 of treatment. The reported data shows that at Day 4, approximately 61.6% of participants had a drop of at least 3 points on the HBI score — this was the primary (main) measurement the trial was designed to capture. By Week 1, the reported figure rose to around 75.6% of participants meeting that same threshold. For a separate measure — remission, meaning an HBI score below 5 — the reported data shows approximately 54.7% of participants reached that point by Weeks 2 and 4 combined, rising to around 62.8% by Week 4 alone. The trial also tracked quality-of-life scores using two questionnaires over 12 weeks. On a general health scale (where 1 represents full health), participants' average score at the start was reported as 0.62, and the average change by Week 12 was reported as an increase of 0.14. On a separate self-rated health scale out of 100, the average starting score was reported as 55.4, with an average change of plus 15.4 points by Week 12. A bowel-disease-specific quality-of-life questionnaire (scored from 7 to 252, with higher being better) showed an average starting score of 145.1 and an average reported change of plus 44.7 points by Week 12. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Crohn's Disease and Colitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Crohn's disease for at least 4 months.
- Your Crohn's disease is currently active and considered moderate to severe (based on a symptom scoring system called the Harvey-Bradshaw Index).
- You have already tried steroid medications and/or immune-suppressing medications, but they did not work well enough for you.
- If you are taking anti-inflammatory medications (aminosalicylates), probiotics, painkillers, anti-diarrhea medications, or Crohn's-related antibiotics, your dose has been the same for at least the last 4 weeks.
- If you are taking azathioprine, 6-mercaptopurine, or methotrexate, your dose has been the same for at least the last 12 weeks.
- If you are taking steroid tablets (such as budesonide up to 9mg/day or prednisone up to 40mg/day), your dose has not been increased in the last 2 weeks (a dose reduction is allowed).
Who may not be able to join:
- You have previously been treated with a type of medication called an anti-TNF (anti-Tumor Necrosis Factor) drug.
- You have had bowel surgery in the last 6 months, or have had a large section of bowel removed (more than 100 cm), or have short bowel syndrome.
- Your Crohn's disease involves fistulas (abnormal tunnels forming between body parts).
- You have taken cyclosporine or tacrolimus (immune-suppressing drugs) within the last 8 weeks.
- You have significant heart problems, such as unstable chest pain, a heart attack within the last 6 months, or moderate-to-severe heart failure.
- You have a stoma bag, ostomy, or have had certain types of bowel removal surgery such as a total colectomy, ileostomy, or pouch surgery (confirm with trial site if unsure about your specific surgery).
- Your blood test results taken during screening fall outside acceptable ranges (confirm specific values with trial site).
- You have a known Hepatitis C infection.
- Your blood tests show signs of a current or past Hepatitis B infection.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
Percentage of Participants With Clinical Response at Day 4
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.