The trial and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Enbrel has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. The signs and symptoms of active ankylosing spondylitis in adults. Golimumab: Simponi, alone or in combination with methotrexate, is indicated for: The treatment of active and progressive psoriatic arthritis in trial patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Simponi has also been shown to inhibit the progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function. Simponi is indicated for: The treatment of active ankylosing spondylitis in adult patients. Regulatory status The product received initial registration on the Australian Register of Therapeutic Goods (ARTG) on 20 January 2010. Certolizumab was considered by Advisory Committee on Prescription Medicines (ACPM) (previously ADEC) at the trial meeting (October 2009), leading to its approval in 2010 for rheumatoid arthritis. At the time the TGA considered this application, a similar application had been approved in the United States (US), Canada and had been submitted in the European Union (EU). Applications had not been submitted in Switzerland or New Zealand. Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent Product Information please refer to the TGA website at <>. II. Quality findings was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found in Attachment 2.
The and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Enbrel has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. The signs and symptoms of active ankylosing spondylitis in adults. Golimumab: Simponi, alone or in combination with methotrexate, is indicated for: The treatment of active and progressive psoriatic arthritis in patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Simponi has also been shown to inhibit the progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, and improve physical function. Simponi is indicated for: The treatment of active ankylosing spondylitis in adult patients. Regulatory status The product received initial registration on the Australian Register of Therapeutic Goods (ARTG) on 20 January 2010. Certolizumab was considered by Advisory Committee on Prescription Medicines (ACPM) (previously ADEC) at the meeting (October 2009), leading to its approval in 2010 for rheumatoid arthritis. At the time the TGA considered this application, a similar application had been approved in the United States (US), Canada and had been submitted in the European Union (EU). Applications had not been submitted in Switzerland or New Zealand. Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent Product Information please refer to the TGA website at <>. II. Quality findings was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found in Attachment 2. trial trial trial
auspar-certolizumab-140815.docx