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Study Complete
Sponsor ID
20020133

Evaluating the Safety of Extended Treatment with Pegsunercept (PEG sTNF-RI)in Subjects with Rheumatoid Arthritis (RA)

Sponsor ID
20020133
Clinicaltrials.gov ID
NCT00111423
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
pegsunercept
Type
Interventional
Masking
N/A
Enrollment
216
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Rheumatoid Arthritis
    • Sex
    N/A
    Trial Dates
    Aug 2002 - N/A
    Inclusion and Exclusion Criteria
    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