Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Multicentre, Randomised, Open Label Study Comparing a Scheduled Steroid Reduction Strategy Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233558

Enrollment

160

Registered

2005-10-06

Start date

2005-06-30

Completion date

Unknown

Last updated

2007-04-24

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

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX

Interventions

DRUGadalimumab (up to 9 months exposure)

DRUGmethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history * Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria

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
Corticoid reduction and DAS 28	—

Secondary

Measure	Time frame
Patient reported outcomes	—
Clinical response indicators	—
Safety parameters	—

Countries

United States

Outcome results

None listed

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