Gordon 2001.
Methods | Randomized, double‐blind, placebo‐controlled, multi‐center, 12 week induction trial Table of random numbers |
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Participants | 30 adult patients with mild to moderate Crohn's disease (CDAI of > 151 and < 450) Oral corticosteroids (< 40 mg prednisolone or < 9 mg budesonide per day) permitted if dose was stable within 2 weeks of entry 5‐ASA, AZA or 6‐MP permitted provided treatment was not started within 2 months or the dose increased within 4 months of entry Female patents had to use contraception Exclusion criteria: pregnancy or breast feeding, weight > 100 kg, CDAI > 450 or inpatient due to Crohn's, patients treated with CYA, MTX or TAC, abdominal surgery within 3 months of entry or need for surgery, ileostomy or colostomy, laboratory‐confirmed intestinal infection, malignant neoplasm |
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Interventions | Patients received one infusion of natalizumab (3 mg/kg; n = 18) or placebo (n = 12) | |
Outcomes | The primary outcome was the change in mean CDAI at two weeks post‐infusion Secondary outcomes: remission (CDAI < 150), IBDQ, serum levels of CRP, ESR, blood count, peripheral blood T cells and B cells, serum natalizumab and anti‐natalizumab antibody concentrations Patients were evaluated at study entry and at weeks one, two, four, eight and twelve post‐infusion |
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Notes | Industry‐support: funded by Elan pharmaceuticals | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers |
Allocation concealment (selection bias) | Low risk | Individual randomization concealment codes were held by the trial’s sponsor and each hospital’s pharmacy for emergency use, and none were opened during the study |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind: investigators and patients remained blinded to the randomization codes until data analysis was complete |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Patient withdrawals were described and distributed evenly across treatment groups |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |