Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age: at least 18 years
CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
A Harvey-Bradshaw score between 5 and 12
Males and non-pregnant, non-nursing women
Mild to moderate active CD, defined by a CDAI score between 180 and 350
Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
Estimated creatinine clearance should be above 75 ml/min
You may not be if
Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial
CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
Prior treatment resistance to Pentasa (mesalazine)
Chronic, dominant arthralgia or rheumatoid arthritis
Palpable abdominal mass
Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
Positive pregnancy test
Clareo Health | A Study With Pentasa in Patients With Active Crohn's Disease