Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2013 |
End Date: | May 2015 |
A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis
This extension study will provide continuing treatment with secukinumab for up to 3 years
for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered
maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The
study aims to obtain further long term efficacy, safety and tolerability information on
secukinumab for patients with rheumatoid arthritis.
for subjects who completed the phase III core study, CAIN457F2302. Subjects will be offered
maintenance treatment with secukinumab at the 150 mg given subcutaneously every 4 weeks. The
study aims to obtain further long term efficacy, safety and tolerability information on
secukinumab for patients with rheumatoid arthritis.
Inclusion Criteria:
Subjects must give a written informed consent before any assessment is performed.
Subjects must have completed the 104-week treatment period in the core study Subjects who
are deemed by the investigator to benefit from continued secukinumab therapy.
Exclusion Criteria:
Use of other investigational drugs except for secukinumab during the core study.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of becoming
pregnant, unless they are using effective methods of contraception during dosing of study
treatment.
We found this trial at
19
sites
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