Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Inflammation, Pegsunercept, PEG sTNF-RI, Autoimmune, Amgen, Clinical Trials
Brief summary
The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.
Interventions
DRUGPegsunercept (PEG sTNF-RI)
Sponsors
Amgen
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
- Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - The subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed
Exclusion criteria
- Greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study - Any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent - Concurrent treatment with an investigational agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of RA assessment outcomes | — |
| Assessment of Compliance | — |
Outcome results
None listed