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Study record managers: refer to the Data Element Definitions if submitting registration or information. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.

Drug: Double-blind Placebo Double-blind adalimumab-matching placebo administered subcutaneously SC every other week eow Other Name: Placebo Experimental: DB adalimumab Participants received double-blind adalimumab 40 mg administered subcutaneously SC every other week eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.

Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions 0 [no damage] to 5 [complete collapse or total destruction of t] and for t space narrowing 0 [no damage] to 4 [complete luxation of t]. Scores were added, giving total mTSS 0 [normal] to [maximal disease]. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.

Calculation of the DAS28 score used the tender shizuuoka count 28 tsswollen t count 28 tspatient's global assessment of disease activity, and the erythrocyte sedimentation rate.

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DAS28 ESR tfxt range from 0 no disease activity to 9 maximal disease activity ; decrease is indicative of improvement in disease activity. The of participants who experienced any adverse event serious or non-serious while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.

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Adverse events were collected at deated study visits for all participants who were randomized and received at least 1 dose of adalimumab. Participants received double-blind adalimumab 40 mg administered subcutaneously SC every other week eow for up to 26 weeks. Actual Enrollment :. Sdx Information. Please refer to this study by its ClinicalTrials.

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Eligible participants were randomized to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week eow during the week double-blind phase. Open-label adalimumab 40 mg administered subcutaneously SC every other week eow after completion of the first 26 weeks in the study. Outcome Measures. Participants received double-blind placebo administered subcutaneously SC every other week eow and then open-label adalimumab 40 mg SC eow as rescue treatment as eligible at Week 12 or after to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks.

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