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Trial · Interventional

CompletedPhase 2Registry data

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

Short name AGRA

NCTNCT00667758 (opens ClinicalTrials.gov in a new tab)Other idR1/05Other id2007/2/0174
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
104 participants (actual)
Sponsor
Betanien Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

Norway

Start
May 2008
Primary completion
Jun 2011
Completion
Oct 2011
First posted
28 Apr 2008 (estimated)
Last update posted
6 Aug 2012 (estimated)
Conditions
Rheumatoid Arthritis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. Ph 2

    AGRA

    NCT00667758

    May 2008 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CetrorelixDrug
  • PlaceboDrug

Arms2

  • Experimental

    1

    Cetrorelix

  • Placebo comparator

    2

    NaCl solution

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · From baseline to day 5

Secondary outcomes(9)

  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

    Registry description

    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

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

9 results

Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial.

Kåss et al. 2015PloS onecited by 16

PMID 26460564PMC4603957DOI 10.1371/journal.pone.0139439PUB-26460564

CC BY9 results
Download PDFSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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