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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Cetrorelix

• Registration Number: NCT00667758
• Lead Sponsor: Betanien Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Study Start: 2008-05
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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Exclusion Criteria

• Patients who are pregnant or breastfeeding
• Patients taking biologic therapy or prednisolone >7.5mg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	NaCl solution
1	Cetrorelix	Cetrorelix

Primary Outcome Measures

Name	Time	Method
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group	From baseline to day 5

Secondary Outcome Measures

Name	Time	Method
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	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.
Change in ACR core set measures	From baseline to day 2/5/10/15
Adverse events	Baseline up to day 15	Number of patients with adverse events (and serious adverse events) up to day 15 in each group

Trial Locations

Locations (1)

Deaprtment of Rheumatology, Betanien Hospital; 🇳🇴 Skien, Norway