A Phase 3 interventional study of ADALIMUMAB and Placebo in Crohn's Disease and Mucosal Inflammation, sponsored by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa. Terminated at 30 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Phase 3, Interventional, and Treatment
This study will test that individualized treatment in patients with Crohn's Disease in remission or mild clinical activity under immunosuppressants may improve prognosis, rather than just treating flares.
Patients will be prescreened for inclusion criteria one week before the start of screening at Visit 0 (Prescreening Visit). Patients must be on stable doses of azathioprine/mercaptopurine. Patients will be given a diary to record their CD symptoms for the seven days prior to Visit 1. At Visit 1 (Screening Visit 1), patients will have their CDAI score assessed based upon their diary information. Patients with CDAI ≤ 220 will then have both calprotectin and hsCRP testing done. Patients with calprotectin > or = 250µg/g and/or hsCRP > or = 5mg/L will be notified and told to schedule Visit 2 within three weeks. At Visit 2 (Screening Visit 2), patients will undergo a colonoscopy. A Crohn's Disease Endoscopic Index of Severity (CDEIS) will be used to determine the endoscopic activity. Patients with significant endoscopic lesions will be notified and asked to enroll in the study.
Patients will be randomized into the study at Visit 3 (Randomization Visit, same day of Visit 2 in results available). Due to the cost and invasiveness of the colonoscopy, the Screening Visit 2 colonoscopy will serve as the baseline for the study, should the patient be enrolled. Drug will also be dispensed at this visit. Eligible patients will be randomized in a 1:1 ratio to receive either adalimumab or placebo during the treatment period, along with continuing their current immunosuppressive maintenance treatment at a stable dose. Treatment in both arms will be induction at 160/80mg and maintenance on 40 mg every other week.
Patients will return for follow up visits every 12 weeks until the final follow-up visit at 48 weeks (Visit 7), where another colonoscopy will be performed. Patients who terminate early from the study for any reason will be asked to return for a follow-up visit, where Visit 7 procedures will be performed.
Before week 48, if a patient has an increase of more than 50% in either calprotectin and/or hsCRP over baseline and above the thresholds at any regular visit, a follow-up visit will be performed two weeks later. If the 50% increase is still observed another colonoscopy will be performed, within two weeks of the follow-up visit. If patients still have significant endoscopic lesions, study product will be intensified to 40 mg weekly. This will include patients on placebo in order to preserve the double-blind aspect of the study.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 15 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Concomitant treatment with:
Patients receiving therapy with azathioprine/mercaptopurine must have been on a stable dose for at least 12 weeks before inclusion and must continue with the same dose during the study.
No treatment with other known immunomodulators (eg. methotrexate, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, ustekinumab, pentoxifylline, or mycophenolate mofetil) or experimental drugs (eg., factor colony stimulating granulocyte macrophage [GM-CSF]) within 6 months
Aspirin or Non-steroidal anti-inflammatory drugs (NSAIDs). Treatment with aspirin and/or NSAIDS should not occur for more than 15 consecutive days before collecting of the stool sample for Calprotectin and performing the colonoscopy.
Serum creatinine > 1.6 mg/dL (144 μmol/L)
Treatment with placebo
Drug: Placebo
Treatment with Adalimumab
Drug: ADALIMUMAB
Adalimumab at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly.
Also known as: HUMIRA
PLACEBO at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly
The primary efficacy endpoint is the rate of therapeutic failure up to week 48
The therapeutic failure is defined as any of following cases: 1. CDAI \> 220 with at least 70-point increase from baseline over two consecutive visits 12 weeks apart or CDAI \> 300 at any time point during the study; 2. need of any change in therapy for CD except the ones planned per protocol in each group of the study; 3. need of surgery related to CD or of stricture endoscopic dilatation.
Time frame: Every 12 weeks up to Week 48
The rate of therapeutic failure (see the definition of primary endpoint) up to week 24
Time frame: up to week 24
Change in CDEIS from baseline to week 48
CDEIS = Crohn's Disease Endoscopic Index of Severity.
Time frame: up to week 48
The rate of mucosal healing (CDEIS=0) at week 48
CDEIS = Crohn's Disease Endoscopic Index of Severity
Time frame: at week 48
The rate of CDEIS remission (CDEIS<=3) at week 48
CDEIS = Crohn's Disease Endoscopic Index of Severity
Time frame: at week 48
The rate of CDEIS response, which is defined as a decrease of at least 4 points in CDEIS from baseline to week 48
CDEIS = Crohn's Disease Endoscopic Index of Severity
Time frame: from baseline up to week 48
Change in CDAI from baseline to week 12, 24, 36 and 48
CDAI = Crohn's Disease Activity Index.
Time frame: from baseline to week 12, 24, 36 and 48
Change in the global score based on IBDQ from baseline to week 12, 24, 36, and 48.
IBDQ = Inflammatory Bowel Disease Questionnaire.
Time frame: from baseline to week 12, 24, 36, and 48.
Area Under the Curve (AUC) over 48 weeks for CDAI
Time frame: 48 weeks
The number of surgical interventions related to CD up to 24 and 48 weeks
Time frame: up to 24 and 48 weeks
The rate of hospital admissions related to the disease, to the treatment side effects or other causes up to weeks 24 or 48
Time frame: up to weeks 24 or 48
The rate of serious AEs between the two strategies up to 24 and 48 weeks
Time frame: up to 24 and 48 weeks
The rate of serious AEs requiring the cessation of the ongoing treatment between the two strategies up to 24 and 48 weeks.
Time frame: up to 24 and 48 weeks
The accuracy of calprotectin/hsCRP to predict therapeutic failure 12 weeks in advance
Time frame: 12 weeks
The correlation between calprotectin, hsCRP and CDAI at any time points during the study.
Pearson Product-Moment Correlation will be used to evaluate correlations between calprotectin, hsCRP and CDAI at all scheduled visits.
Time frame: 48 weeks
The correlation between calprotectin/hsCRP and CDEIS or mucosal healing at Baseline and Week 48.
Pearson Product-Moment Correlation will also be used to evaluate between calprotectin (and hsCRP) and CDEIS at Baseline and Week 48.
Time frame: at Baseline and Week 48.
Change in the scores based on WPAI from baseline to week 12, 24, 36 and 48
WPAI = Work Productivity and Activity Impairment Questionnaire
Time frame: from baseline to week 12, 24, 36 and 48
The change in calprotectin and hsCRP from baseline to week 12, 24, 36, and 48
Time frame: from baseline to week 12, 24, 36, and 48
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Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa