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NCT01679951 · ClinicalTrials.gov registry record · Phase 2

A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

A Phase 2 study, sponsored by Janssen Research & Development.

Terminated
Registry status
Phase 2
Development phase
272
Enrollment target

NCT01679951: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.

NCT01679951 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 272 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01679951, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.

TERMINATED
Registry status
Phase 2
Development phase
272 participants
Enrollment target

Study Summary

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

Primary Outcome

The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and Patient's Global Assessment of Disease Activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=bes

Interventions

  • DRUG Placebo
  • DRUG Methotrexate
  • DRUG JNJ-38518168 (30 mg)
  • DRUG JNJ-38518168 (10 mg)
  • DRUG JNJ-38518168 (3 mg)

Trial Details

FieldValue
Enrollment Target 272 participants
Start Date 2012-10-31
Est. Completion 2014-07-03
Phase Phase 2
Janssen Research & Development

593 total trials

Why NCT01679951 stopped before completion

NCT01679951 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (105% higher).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01679951 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01679951 about?

NCT01679951 is a clinical study titled "A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate". The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

What is the current status of trial NCT01679951?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 272 participants. The study started on 2012-10-31. Estimated completion is 2014-07-03.

What interventions are being tested in trial NCT01679951?

The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), JNJ-38518168 (30 mg) (DRUG), JNJ-38518168 (10 mg) (DRUG), JNJ-38518168 (3 mg) (DRUG).

Who is sponsoring clinical trial NCT01679951?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01679951's enrollment target sits among peer trials

272 204th of 2000 higher than 1,796 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 NCT01679951, the US trial registry maintained by the National Library of Medicine. NCT01679951 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.