Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234936

Enrollment

200

Registered

2005-10-10

Start date

2003-12-31

Completion date

Unknown

Last updated

2007-10-03

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

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, adalimumab, quality of life

Brief summary

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.

Interventions

DRUGAdalimumab

DRUGMethotrexate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

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 ACR criteria * Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

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 * Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

Design outcomes

Primary

Measure	Time frame
QOL	12 months

Secondary

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

Outcome results

None listed

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