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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

April 24, 2008
August 3, 2012
May 2008
June 2011   (final data collection date for primary outcome measure)
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group [ Time Frame: From baseline to day 5 ] [ Designated as safety issue: No ]
Change in Disease Activity Score (DAS28) in cetrorelix group versus placebo group [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00667758 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis
Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Cetrorelix
    3-5 mg s.c. on days 1-5
  • Drug: Placebo
    3-5 ml NaCl s.c. on days 1-5
  • Experimental: 1
    Cetrorelix
    Intervention: Drug: Cetrorelix
  • Placebo Comparator: 2
    NaCl solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00667758
R1/05, 2007/2/0174
Yes
Anita Kass, Betanien Hospital
Betanien Hospital
  • Norwegian Foundation for Health and Rehabilitation
  • University of Oslo
Principal Investigator: Kåss University of Oslo
Betanien Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP