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NCT02270957 · ClinicalTrials.gov registry record · Phase 2

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

A Phase 2 study, sponsored by Oklahoma Medical Research Foundation.

Completed
Registry status
Phase 2
Development phase
66
Enrollment target

NCT02270957 is a Phase 2 study that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 66 participants.

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The verdict

NCT02270957, a Phase 2 study, has completed, sponsored by Oklahoma Medical Research Foundation.

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target

Study Summary

This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swollen joints and \</= 20 mg prednisone have other background immune suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol (in two or more injections) between the screening visit and the visit 2 months after dosing begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3 months of treatment patients who are not responding may elect to receive open label abatacept with or without additional standard of care therapies. Such patients are considered non responders. The primary endpoint is the British Isles Lupus Assessment Group Index (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant improvement in arthritis and other active features of lupus

Interventions

  • OTHER Placebo
  • BIOLOGICAL Abatacept

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2014-01
Est. Completion 2021-12
Phase Phase 2

What the Registry Record Tells You About NCT02270957

The ClinicalTrials.gov registry entry for NCT02270957 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.

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

NCT02270957 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02270957 about?

NCT02270957 is a clinical study titled "Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches". This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swollen joints and \</= 20 mg prednisone have other background immune suppressants withdrawn at entry. The...

What is the current status of trial NCT02270957?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2014-01. Estimated completion is 2021-12.

What interventions are being tested in trial NCT02270957?

The interventions under investigation include: Placebo (OTHER), Abatacept (BIOLOGICAL).

Who is sponsoring clinical trial NCT02270957?

This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.

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

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