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

Betanien Hospital

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Cetrorelix; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00667758

2007/2/0174 (Other Grant/Funding Number)

R1/05

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Cetrorelix

Treatment:

Drug: Cetrorelix

2

Placebo Comparator group

Description:

NaCl solution

Treatment:

Drug: Placebo