Chaudhari 2001.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: not stated Location: single centre, New Jersey, USA |
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Participants |
Randomised: 33 participants (age mean 35 years (infliximab 10), 51 years (infliximab 5), 45 years (placebo), 23 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Infliximab (n = 11), IV, 5 mg/kg, weeks 0, 2, 6, 10 Control intervention B. Infliximab (n = 11), IV, 10 mg/kg, weeks 0, 2, 6, 10 C. Placebo (n = 11), IV, 20 mL, weeks 0, 2, 6, 10 |
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Outcomes | Assessment at 10 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding: Y Johnson and Johnson, Centocor Inc Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p 1843): "...were randomly assigned... by means of a lock‐of‐six randomisation scheme" Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (p 1843): "Placebo was supplied in a identical manner except that it did not contain IFX...The infliximab infusion solution was given by investigators unaware of treatment assignment..." Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (p 1843): "All assessments were done in a masked manner" Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomly assigned 33, analysed 33 Dropouts and withdrawals
Management of missing data: Quote (p 1844): "The primary analysis was done according to ITT, all randomised patients were included" Comment: probably done |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |