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NCT00559585 · ClinicalTrials.gov registry record · Phase 3

Methotrexate-Inadequate Response Study

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
2,492
Enrollment target

NCT00559585: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT00559585 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 2,492 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (223% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00559585, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
2,492 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Primary Outcome

The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joints, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein).

Interventions

  • DRUG Subcutaneous (SC) Abatacept
  • DRUG Intravenous (IV) Abatacept

Trial Details

FieldValue
Enrollment Target 2,492 participants
Start Date 2008-01
Est. Completion 2014-09
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00559585 record still lists

NCT00559585 is an interventional study that assigns participants to a tested intervention. Its 2,492 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (223% higher).

The record links to 0 conditions, and to 2 interventions - of which Subcutaneous (SC) Abatacept is the first listed.

NCT00559585 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00559585 about?

NCT00559585 is a clinical study titled "Methotrexate-Inadequate Response Study". The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

What is the current status of trial NCT00559585?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,492 participants. The study started on 2008-01. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00559585?

The interventions under investigation include: Subcutaneous (SC) Abatacept (DRUG), Intravenous (IV) Abatacept (DRUG).

Who is sponsoring clinical trial NCT00559585?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00559585's enrollment target sits among peer trials

2,492 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00559585, the US trial registry maintained by the National Library of Medicine. NCT00559585 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.