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NCT00853385 · ClinicalTrials.gov registry record · Phase 3

A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
717
Enrollment target

NCT00853385: Completed Phase 3 study, sponsored by Pfizer.

NCT00853385 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 717 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00853385, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
717 participants
Enrollment target

Study Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Primary Outcome

ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); 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). For comparison of CP-690,550 wit

Interventions

  • OTHER Placebo
  • DRUG CP-690,550
  • DRUG CP 690,550
  • BIOLOGICAL Biologic TNFi

Trial Details

FieldValue
Enrollment Target 717 participants
Start Date 2009-05
Est. Completion 2011-03
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00853385 record still lists

NCT00853385 is an interventional study that assigns participants to a tested intervention. The registered 717 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00853385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00853385 about?

NCT00853385 is a clinical study titled "A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis". This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult pa...

What is the current status of trial NCT00853385?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 717 participants. The study started on 2009-05. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00853385?

The interventions under investigation include: Placebo (OTHER), CP-690,550 (DRUG), CP 690,550 (DRUG), Biologic TNFi (BIOLOGICAL).

Who is sponsoring clinical trial NCT00853385?

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 NCT00853385's enrollment target sits among peer trials

717 498th of 2000 higher than 1,503 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 NCT00853385, the US trial registry maintained by the National Library of Medicine. NCT00853385 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.