Weinblatt 1999.
| Methods | Method of randomisation not reported Allocation concealment not reported Double blinding Multicentre, parallel group study Power calculation for sample size No of participants randomised = 89 No of participants analysed = 89 (2 withdrew in etanercept group because of adverse events; 4 withdrew in MTX group because of lack of efficacy, 1 because of myocardial infarction, 1 lost to follow‐up) Intention‐to‐treat analysis (participants who withdrew were considered not to have a response and for individual measures, last observation was used in the analysis) Source of funding: Immunex (pharmaceutical company) | |
| Participants | Inclusion: ≥ 18 years of age; diagnosis of RA; active disease Exclusion not reported Location: centres in North America | |
| Interventions |
All participants had been taking MTX prior to study for at least 6 months All participants received folic acid and were allowed to use NSAIDs or steroids during study Duration: 6 months |
|
| Outcomes | ACR20, ACR50, ACR70 Radiographic: TJC; SJC HAQ Adverse events Withdrawals | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No method of randomisation described |
| Allocation concealment (selection bias) | Unclear risk | No description of method used to conceal allocation |
| Blinding (performance bias and detection bias) Clinical outcomes | Low risk | Stated as "double blinded" |
| Incomplete outcome data (attrition bias) Clinical outcomes | Low risk | Clear descriptions of reasons for withdrawal of dropouts |
| Selective reporting (reporting bias) | Low risk | No prior published protocol identified but wide range of outcomes measured |
| Other bias | Unclear risk | Drug company funding with no guarantees described to prevent influence on results |
ACR: American College of Rheumatology; CRP: C reactive protein; DAS: disease activity score; DMARD: disease‐modifying anti‐rheumatic drug; ESR: erythrocyte sedimentation rate; EULAR: European League Against Rheumatism; h: hour; HAQ: Health Assessment Questionnaire; LOCF: last observation carried forward; MTX: methotrexate; NSAID: non‐steroidal anti‐inflammatory drug; PBO: placebo; RA: rheumatoid arthritis; RF+: rheumatoid factor positive; SC: subcutaneous; SJC: swollen joint count; SSZ: sulphasalazine; TB: tuberculosis; TJC: tender joint count; TNF: tumour necrosis factor; TSS: Total Sharp Score; VAS: visual analogue scale.