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Completed

NCT Number: NCT00195494

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

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Denver, Colorado, 80230, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
  • Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion criteria

  • Received any previous treatment with MTX
  • Received any previous treatment with ETN or other tumour necrosis factor antagonist

Treatment and study plan

etanercept

Drug

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

methotrexate

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.

    Time frame: 12 months

    Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.

  2. Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.

    Time frame: 12 months

    The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.

Secondary outcomes

  1. Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death

    Time frame: 12 and 24 months

    Safety report for entire trial where participants reported a serious adverse event that led to death.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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