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

Sponsor:	Betanien Hospital
Collaborators:	Norwegian Foundation for Health and Rehabilitation University of Oslo
Information provided by (Responsible Party):	Anita Kass, Betanien Hospital
ClinicalTrials.gov Identifier:	NCT00667758

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: Cetrorelix Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Cetrorelix Cetrorelix acetate LH-RH

U.S. FDA Resources

Further study details as provided by Betanien Hospital:

Primary Outcome Measures:

Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group [ Time Frame: From baseline to day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	98
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cetrorelix	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667758

Locations

Norway
Deaprtment of Rheumatology, Betanien Hospital
Skien, Norway

Sponsors and Collaborators

Betanien Hospital

Norwegian Foundation for Health and Rehabilitation

University of Oslo

Investigators

Principal Investigator:

Kåss

University of Oslo

More Information

No publications provided

Responsible Party:	Anita Kass, Dr Anita Kåss, Betanien Hospital
ClinicalTrials.gov Identifier:	NCT00667758 History of Changes
Other Study ID Numbers:	R1/05, 2007/2/0174
Study First Received:	April 24, 2008
Last Updated:	October 12, 2011
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Directorate for Health and Social Affairs; Norway: Data Inspectorate; Norway: The National Committees for Research Ethics in Norway

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Cetrorelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012