Rheumatoid Arthritis
Conditions
Brief summary
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis
Interventions
DRUGadalimumab
DRUGmethotrexate
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Subject must be in paid employment * Subject has self-reported work impairment since onset of symptoms
Exclusion criteria
* A subject has chronic arthritis diagnosed before age 16 years. * Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs * Subject has preceding treatment with any biological TNF antagonist * 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 |
|---|---|
| Job loss measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Job productivity measurements | — |
| Patient reported outcomes | — |
| DAS28 | — |
| Safety parameters | — |
Countries
United States
Outcome results
None listed