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Completed

NCT Number: NCT00667758

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Deaprtment of Rheumatology, Betanien Hospital

Skien, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetrorelix

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: From baseline to day 5

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Betanien Hospital

Other

Collaborators

  • Norwegian Foundation for Health and Rehabilitation
  • University of Oslo

Registry information

Official study title

Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Acronym: AGRA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2008
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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