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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00667758
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : August 6, 2012
Norwegian Foundation for Health and Rehabilitation
University of Oslo
Information provided by (Responsible Party):
Anita Kass, 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Cetrorelix Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
Study Start Date : May 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group [ Time Frame: From baseline to day 5 ]

Secondary Outcome Measures :
  1. Change in DAS28 (CRP/ESR) [ Time Frame: From baseline to day 2/5 /10/15 ]
  2. Change in anti-CCP level [ Time Frame: From baseline to day 2/5/10/15 ]
  3. Change in cytokine level [ Time Frame: From baseline to day 2/5/10/15 ]
  4. Change in ACR core set measures [ Time Frame: From baseline to day 2/5/10/15 ]
  5. Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders [ Time Frame: Baseilne to day 2/5/10/15 ]
  6. Adverse events [ Time Frame: Baseline up to day 15 ]
    Number of patients with adverse events (and serious adverse events) up to day 15 in each group

  7. Proportion of patients with DAS28low disease activity/remission [ Time Frame: Baseline to day 2/5/10/15 ]
  8. Change in HAQ scores [ Time Frame: From baseline to day 5/10/15 ]
  9. Correlation between percent changes in hormones, disease activity and biomarkers [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00667758

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anita Kass, Dr Anita Kåss, Betanien Hospital Identifier: NCT00667758     History of Changes
Other Study ID Numbers: R1/05
2007/2/0174 ( Other Grant/Funding Number: Norwegian Foundation for Health and Rehabilitation )
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists