NCT00667758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started May 2008

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

3.1 years

First QC Date

April 24, 2008

Last Update Submit

August 3, 2012

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

    From baseline to day 5

Secondary Outcomes (9)

  • Change in DAS28 (CRP/ESR)

    From baseline to day 2/5 /10/15

  • Change in anti-CCP level

    From baseline to day 2/5/10/15

  • Change in cytokine level

    From baseline to day 2/5/10/15

  • Change in ACR core set measures

    From baseline to day 2/5/10/15

  • Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders

    Baseilne to day 2/5/10/15

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Cetrorelix

Drug: Cetrorelix

2

PLACEBO COMPARATOR

NaCl solution

Drug: Placebo

Interventions

CetrorelixDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who are pregnant or breastfeeding
  • Patients taking biologic therapy or prednisolone \>7.5mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deaprtment of Rheumatology, Betanien Hospital

Skien, Norway

Location

Related Publications (1)

  • Kass A, Hollan I, Fagerland MW, Gulseth HC, Torjesen PA, Forre OT. Rapid Anti-Inflammatory Effects of Gonadotropin-Releasing Hormone Antagonism in Rheumatoid Arthritis Patients with High Gonadotropin Levels in the AGRA Trial. PLoS One. 2015 Oct 13;10(10):e0139439. doi: 10.1371/journal.pone.0139439. eCollection 2015.

    PMID: 26460564DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kåss

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anita Kåss

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2011

Study Completion

October 1, 2011

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

NO(1)