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

Betanien Hospital104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Rheumatoid Arthritis

Interventions

CetrorelixDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Deaprtment of Rheumatology, Betanien Hospital

Skien, Norway

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 DAS28 (CRP/ESR)

Time frame: From baseline to day 2/5 /10/15

Change in anti-CCP level

Time frame: From baseline to day 2/5/10/15

Change in cytokine level

Time frame: From baseline to day 2/5/10/15

Change in ACR core set measures

Time frame: 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

Adverse events

Number of patients with adverse events (and serious adverse events) up to day 15 in each group

Time frame: Baseline up to day 15

Proportion of patients with DAS28low disease activity/remission

Time frame: Baseline to day 2/5/10/15

Change in HAQ scores

Time frame: From baseline to day 5/10/15

Correlation between percent changes in hormones, disease activity and biomarkers

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.

Data from ClinicalTrials.gov

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