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NCT01645280 · ClinicalTrials.gov registry record · Phase 2

A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

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

Completed
Registry status
Phase 2
Development phase
274
Enrollment target

NCT01645280 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 274 participants.

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The verdict

NCT01645280, a Phase 2 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
274 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Interventions

  • DRUG Placebo + methotrexate (MTX) (Group 1)
  • DRUG Ustekinumab + MTX (Group 2)
  • DRUG Ustekinumab + MTX (Group 3)
  • DRUG CNTO 1959 + MTX (Group 4)
  • DRUG CNTO 1959 + MTX (Group 5)

Trial Details

FieldValue
Enrollment Target 274 participants
Start Date 2012-08
Est. Completion 2014-05
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01645280

The ClinicalTrials.gov registry entry for NCT01645280 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo + methotrexate (MTX) (Group 1) is the first listed.

NCT01645280 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01645280 about?

NCT01645280 is a clinical study titled "A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy". The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population...

What is the current status of trial NCT01645280?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 274 participants. The study started on 2012-08. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01645280?

The interventions under investigation include: Placebo + methotrexate (MTX) (Group 1) (DRUG), Ustekinumab + MTX (Group 2) (DRUG), Ustekinumab + MTX (Group 3) (DRUG), CNTO 1959 + MTX (Group 4) (DRUG), CNTO 1959 + MTX (Group 5) (DRUG).

Who is sponsoring clinical trial NCT01645280?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.