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

This study has been completed.
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
University of Oslo
Information provided by (Responsible Party):
Anita Kass, Betanien Hospital
ClinicalTrials.gov Identifier:
NCT00667758
First received: April 24, 2008
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Cetrorelix
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Betanien Hospital:

Primary Outcome Measures:
  • Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group [ Time Frame: From baseline to day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in DAS28 (CRP/ESR) [ Time Frame: From baseline to day 2/5 /10/15 ] [ Designated as safety issue: No ]
  • Change in anti-CCP level [ Time Frame: From baseline to day 2/5/10/15 ] [ Designated as safety issue: No ]
  • Change in cytokine level [ Time Frame: From baseline to day 2/5/10/15 ] [ Designated as safety issue: No ]
  • Change in ACR core set measures [ Time Frame: From baseline to day 2/5/10/15 ] [ Designated as safety issue: No ]
  • Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders [ Time Frame: Baseilne to day 2/5/10/15 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Baseline up to day 15 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to day 2/5/10/15 ] [ Designated as safety issue: No ]
  • Change in HAQ scores [ Time Frame: From baseline to day 5/10/15 ] [ Designated as safety issue: No ]
  • Correlation between percent changes in hormones, disease activity and biomarkers [ Time Frame: By day 2, 5, 10 and 15 ] [ Designated as safety issue: No ]
    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.


Enrollment: 104
Study Start Date: May 2008
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667758

Locations
Norway
Deaprtment of Rheumatology, Betanien Hospital
Skien, Norway
Sponsors and Collaborators
Betanien Hospital
Norwegian Foundation for Health and Rehabilitation
University of Oslo
Investigators
Principal Investigator: Kåss University of Oslo
  More Information

No publications provided

Responsible Party: Anita Kass, Dr Anita Kåss, Betanien Hospital
ClinicalTrials.gov Identifier: NCT00667758     History of Changes
Other Study ID Numbers: R1/05, 2007/2/0174
Study First Received: April 24, 2008
Last Updated: August 3, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Directorate of Health
Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013