Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
115 subjects (57 infliximab (IFX) + MTX and 58 MTX), but only 110 subjects (56 and 54) were considered intent to treat (ITT). Furthermore, 99 subjects (51 + 48) were in a treatment group at Week 16 for Primary Endpoint evaluation.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Infliximab + Methotrexate (IFX + MTX)	Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Methotrexate (MTX)	Oral methotrexate (MTX) 15 mg/week

Participant Flow:   Overall Study

	Infliximab + Methotrexate (IFX + MTX)	Methotrexate (MTX)
STARTED	57[1]	58[2]
COMPLETED	47	47
NOT COMPLETED	10	11
Adverse Event	7	2
Lost to Follow-up	1	0
Withdrawal by Subject	0	4
Protocol Violation	2	5

Reporting Groups

	Description
Infliximab + Methotrexate (IFX + MTX)	Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Methotrexate (MTX)	Oral methotrexate (MTX) 15 mg/week

Baseline Measures

	Infliximab + Methotrexate (IFX + MTX)	Methotrexate (MTX)	Total
Number of Participants   [units: participants]	56	54	110
Age[1] [units: years] Mean ( Full Range )	40.1 ( 20 to 65 )	42.3 ( 21 to 65 )	41.2 ( 20 to 65 )
Gender   [units: participants]
Female	29	21	50
Male	27	33	60

1.  Primary:

Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16   [ between baseline and week 16 ]