Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

PHASE4CompletedINTERVENTIONAL
Enrollment

542

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Etanercept

"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \& 2~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"

DRUG

Methotrexate

"Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 \& 2~Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2~Group 2b: Oral Methotrexate weekly for both Periods 1 and 2"

DRUG

Placebo

"Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2~Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2"

Trial Locations (1)

80230

Denver

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

NCT00195494 - Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter