Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

What Was Tested

In this phase 3 trial, researchers set out to test Relaxin (Serelaxin).

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy.

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

Placebo.

The registry classes the interventions as drug.

Who Took Part

231 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Men and women 18 to 70 years of age with diffuse SSc. Disease duration 5 years since the onset of the first non-Raynaud sign or symptom. A baseline modified Rodnan skin score (MRSS) of 20 or greater, or at least 16 if truncal involvement was present.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Relaxin (Serelaxin) and who got the comparison, which limits bias.

The Relaxin (Serelaxin) group and the comparison group ran side by side rather than switching.

As a double-blind Relaxin (Serelaxin) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 1998-12 with completion listed for 2001-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: MRSS (time frame: baseline, weeks 4,12, and 24).

It also tracked 1 secondary outcome, for example HAQ-DI.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Relaxin (Serelaxin) in 231 people.

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

More context: the Relaxin (Serelaxin) compound page, all human trials.