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NCT00628095 · ClinicalTrials.gov registry record · Phase 2

Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target

NCT00628095: Completed Phase 2 study, sponsored by Pfizer.

NCT00628095 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00628095, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study Summary

CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis

Primary Outcome

ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Interventions

  • DRUG Placebo
  • DRUG CE-224,535

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2008-04-07
Est. Completion 2009-02-04
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT00628095 record still lists

NCT00628095 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00628095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00628095 about?

NCT00628095 is a clinical study titled "Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate". CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug wi...

What is the current status of trial NCT00628095?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2008-04-07. Estimated completion is 2009-02-04.

What interventions are being tested in trial NCT00628095?

The interventions under investigation include: Placebo (DRUG), CE-224,535 (DRUG).

Who is sponsoring clinical trial NCT00628095?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00628095's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00628095, the US trial registry maintained by the National Library of Medicine. NCT00628095 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.