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

Betanien Hospital1 site in 1 country104 target enrollmentMay 2008

ConditionsRheumatoid Arthritis

InterventionsCetrorelix Placebo

DrugsCetrorelix Placebo

Overview

Phase: Phase 2
Intervention: Cetrorelix
Conditions: Rheumatoid Arthritis
Sponsor: Betanien Hospital
Enrollment: 104
Locations: 1
Primary Endpoint: Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

October 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Betanien Hospital

Responsible Party

Principal Investigator

Anita Kass

Dr Anita Kåss

Betanien Hospital

Eligibility Criteria

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

Arms & Interventions

1

Cetrorelix

Intervention: Cetrorelix

2

NaCl solution

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group

Time Frame: From baseline to day 5

Secondary Outcomes

Change in cytokine level(From baseline to day 2/5/10/15)
Change in DAS28 (CRP/ESR)(From baseline to day 2/5 /10/15)
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders(Baseilne to day 2/5/10/15)
Proportion of patients with DAS28low disease activity/remission(Baseline to day 2/5/10/15)
Change in HAQ scores(From baseline to day 5/10/15)
Change in anti-CCP level(From baseline to day 2/5/10/15)
Correlation between percent changes in hormones, disease activity and biomarkers(By day 2, 5, 10 and 15)
Change in ACR core set measures(From baseline to day 2/5/10/15)
Adverse events(Baseline up to day 15)