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

August 3, 2012 updated by: Anita Kass, Betanien Hospital

Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Skien, Norway
        • Deaprtment of Rheumatology, Betanien Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cetrorelix
Drug: Cetrorelix
3-5 mg s.c. on days 1-5
Placebo Comparator: 2
NaCl solution
Drug: Placebo
3-5 ml NaCl s.c. on days 1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
Time Frame: From baseline to day 5
From baseline to day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in DAS28 (CRP/ESR)
Time Frame: From baseline to day 2/5 /10/15
From baseline to day 2/5 /10/15
Change in anti-CCP level
Time Frame: From baseline to day 2/5/10/15
From baseline to day 2/5/10/15
Change in cytokine level
Time Frame: From baseline to day 2/5/10/15
From baseline to day 2/5/10/15
Change in ACR core set measures
Time Frame: From baseline to day 2/5/10/15
From baseline to day 2/5/10/15
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
Time Frame: Baseilne to day 2/5/10/15
Baseilne to day 2/5/10/15
Adverse events
Time Frame: Baseline up to day 15
Number of patients with adverse events (and serious adverse events) up to day 15 in each group
Baseline up to day 15
Proportion of patients with DAS28low disease activity/remission
Time Frame: Baseline to day 2/5/10/15
Baseline to day 2/5/10/15
Change in HAQ scores
Time Frame: From baseline to day 5/10/15
From baseline to day 5/10/15
Correlation between percent changes in hormones, disease activity and biomarkers
Time Frame: By day 2, 5, 10 and 15
This endpoint is not directly related to clinical efficacy. Hormones include LH, FSH, oestradiol, testosterone,and cortisol. Biomarkers include immunologic markers, bone markers and cardiovascular markers. This secondary endpoint was sent to authorities during the study before unblinding.
By day 2, 5, 10 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betanien Hospital

Collaborators

University of Oslo
Norwegian Foundation for Health and Rehabilitation

Investigators

  • Principal Investigator: Kåss, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1/05
  • 2007/2/0174 (Other Grant/Funding Number: Norwegian Foundation for Health and Rehabilitation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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