Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis

Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234897

Acronym

HERO

Enrollment

1938

Registered

2005-10-10

Start date

2004-08-31

Completion date

Unknown

Last updated

2007-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

adalimumab, rheumatoid arthritis

Brief summary

The purpose of the study is to assess the efficacy of adalimumab in subjects with rheumatoid arthritis focusing on subject-reported outcomes and early response to treatment

Interventions

DRUGadalimumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history. * Subject, based on assessment of investigator, meets the definition of active RA

Exclusion criteria

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * Female subject who is pregnant or breast-feeding or considering becoming pregnant

Design outcomes

Primary

Measure	Time frame
Patient reported outcomes, clinical response indicators.	—

Secondary

Measure	Time frame
Subject reported assessments of disease activity, physician reported assessments of disease activity, safety parameters, clinical response indicators.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026