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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Cetrorelix
Placebo
Sponsored by
Betanien Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deaprtment of Rheumatology, Betanien Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Cetrorelix

NaCl solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in DAS28 (CRP/ESR)
Change in anti-CCP level
Change in cytokine level
Change in ACR core set measures
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
Adverse events
Number of patients with adverse events (and serious adverse events) up to day 15 in each group
Proportion of patients with DAS28low disease activity/remission
Change in HAQ scores
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.

Full Information

First Posted
April 24, 2008
Last Updated
August 3, 2012
Sponsor
Betanien Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT00667758
Brief Title
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis
Acronym
AGRA
Official Title
Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Betanien Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation, University of Oslo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cetrorelix
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
NaCl solution
Intervention Type
Drug
Intervention Name(s)
Cetrorelix
Intervention Description
3-5 mg s.c. on days 1-5
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3-5 ml NaCl s.c. on days 1-5
Primary Outcome Measure Information:
Title
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
Time Frame
From baseline to day 5
Secondary Outcome Measure Information:
Title
Change in DAS28 (CRP/ESR)
Time Frame
From baseline to day 2/5 /10/15
Title
Change in anti-CCP level
Time Frame
From baseline to day 2/5/10/15
Title
Change in cytokine level
Time Frame
From baseline to day 2/5/10/15
Title
Change in ACR core set measures
Time Frame
From baseline to day 2/5/10/15
Title
Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders
Time Frame
Baseilne to day 2/5/10/15
Title
Adverse events
Description
Number of patients with adverse events (and serious adverse events) up to day 15 in each group
Time Frame
Baseline up to day 15
Title
Proportion of patients with DAS28low disease activity/remission
Time Frame
Baseline to day 2/5/10/15
Title
Change in HAQ scores
Time Frame
From baseline to day 5/10/15
Title
Correlation between percent changes in hormones, disease activity and biomarkers
Description
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.
Time Frame
By day 2, 5, 10 and 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kåss
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deaprtment of Rheumatology, Betanien Hospital
City
Skien
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26460564
Citation
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.
Results Reference
derived

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

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