NCT00650390
Approved For Marketing
Not Applicable
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab
ConditionsRheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Abbott
- Status
- Approved For Marketing
- Last Updated
- 18 years ago
Overview
Brief Summary
The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females \>= 18 years of age
- •ACR criteria for RA diagnosis for at least 6 months
- •Active RA defined as a DAS 28 \>3.2 at study entry
- •Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
- •A negative pregnancy test for females of childbearing potential
Exclusion Criteria
- •Patient who had previous treatment with cyclophosphamide and chlorambucil
- •Treatment within the last 8 weeks with infliximab
- •Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
- •Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
- •History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
- •Prior treatment with total lymphoid irradiation
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to EtanerceptPlaque PsoriasisNCT00927069Innovaderm Research Inc.85
Completed
Phase 4
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian FederationModerate to Severe Plaque PsoriasisNCT01644396AbbVie (prior sponsor, Abbott)50
Completed
Phase 3
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to EtanerceptPsoriasisNCT00527072Centocor Ortho Biotech Services, L.L.C.217
Unknown
Not Applicable
Anal Crohn Fistula SurgeryCrohn DiseaseFistulaAnoperineal FistulaAnal FistulaNCT01388257French Society of Coloproctology180
Completed
Phase 3
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)Generalized Pustular Psoriasis (GPP)AdalimumabJapaneseNCT02533375AbbVie10