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NCT02480153 · ClinicalTrials.gov registry record · Phase 3

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A Phase 3 study, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
597
Enrollment target

NCT02480153: Completed Phase 3 study, sponsored by Pfizer.

NCT02480153 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 597 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02480153, a Phase 3 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
597 participants
Enrollment target

Study Summary

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

Primary Outcome

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

Interventions

  • BIOLOGICAL Adalimumab
  • BIOLOGICAL PF-06410293

Trial Details

FieldValue
Enrollment Target 597 participants
Start Date 2015-06-25
Est. Completion 2017-12-06
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT02480153 record still lists

NCT02480153 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).

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

NCT02480153 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02480153 about?

NCT02480153 is a clinical study titled "A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).". The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, durin...

What is the current status of trial NCT02480153?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2015-06-25. Estimated completion is 2017-12-06.

What interventions are being tested in trial NCT02480153?

The interventions under investigation include: Adalimumab (BIOLOGICAL), PF-06410293 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02480153?

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 NCT02480153's enrollment target sits among peer trials

597 640th of 2000 higher than 1,361 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 NCT02480153, the US trial registry maintained by the National Library of Medicine. NCT02480153 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.