Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

NCT ID: NCT00667758

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Cetrorelix

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

3-5 mg s.c. on days 1-5

2

NaCl solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3-5 ml NaCl s.c. on days 1-5

Interventions

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Cetrorelix

3-5 mg s.c. on days 1-5

Intervention Type DRUG

Placebo

3-5 ml NaCl s.c. on days 1-5

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult between 18 years and above
* Moderate to severe disease activity
* Negative pregnancy test for women of childbearing potential
* Use of reliable method of contraception (non-hormonal) by sexually active female patients

Exclusion Criteria

* Patients who are pregnant or breastfeeding
* Patients taking biologic therapy or prednisolone \>7.5mg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Betanien Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anita Kass

Dr Anita Kåss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kåss

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Deaprtment of Rheumatology, Betanien Hospital

Skien, , Norway

Site Status

Countries

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Norway

References

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Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial. PLoS One. 2015 Oct 13;10(10):e0139439. doi: 10.1371/journal.pone.0139439. eCollection 2015.

Reference Type DERIVED
PMID: 26460564 (View on PubMed)

Other Identifiers

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2007/2/0174

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R1/05

Identifier Type: -

Identifier Source: org_study_id