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

What Was Tested

This registered phase 2 trial tested Cetrorelix for rheumatoid arthritis.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Cetrorelix.

NaCl solution.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 104 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: patients who are pregnant or breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The rheumatoid arthritis participants were allocated by chance, so the Cetrorelix group and the comparison group should start out alike.

Groups ran in parallel: each of the rheumatoid arthritis participants stayed in one arm throughout.

Blinding on both sides kept the rheumatoid arthritis participants and researchers unaware of who received Cetrorelix.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-05 with completion listed for 2011-06.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group (time frame: From baseline to day 5).

It also tracked 9 secondary outcomes, for example Change in DAS28 (CRP/ESR), Change in anti-CCP level, Change in cytokine level, Change in ACR core set measures, Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cetrorelix in 104 people with rheumatoid arthritis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, Rheumatoid arthritis research.