Trial record 13 of 121 for:
psoriatic arthritis | psoriatic arthritis
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01169844
First received: July 14, 2010
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriatic Arthritis |
Biological: AIN457A |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Psoriatic Arthritis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity) [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunogenicity of AIN457 as measured by anti-AIN457 antibody in serum [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: Yes ]
- Total IL-17 concentration in blood at steady-state [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetics of AIN457 at steady state as measured by AIN457 concentration in serum by a competitive ELISA assay. [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AIN457 | Biological: AIN457A |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A diagnosis of psoriatic arthritis
- Patients who took part in the core CAIN457A2206E1 study
Exclusion Criteria:
- Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2206 study.
- Patients who discontinued from the core CAIN457A2206 study before Visit 14 (Week 16), and patients who completed the core study or discontinued the core study more than 2 weeks before the baseline visit.
- Pregnant or lactating women
- Presence of active infection
- Positive PPD or HIV test in patients where repeated testing was deemed appropriate due to their risk profile
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169844
Locations
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 12203 | |
| Novartis Investigative Site | |
| Hamburg, Germany, 22415 | |
| Novartis Investigative Site | |
| Hamburg, Germany, 22081 | |
| Novartis Investigative Site | |
| Herne, Germany, 44625 | |
| Novartis Investigative Site | |
| Muenchen, Germany, 80336 | |
| Netherlands | |
| Novartis Investigative Site | |
| Amsterdamn, DE, Netherlands, 1100 | |
| Novartis Investigative Site | |
| Meerssen, KR, Netherlands, 6231 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Glasgow, United Kingdom, G12 8TA | |
| Novartis Investigative Site | |
| Leeds, United Kingdom, LS7 4SA | |
| Novartis Investigative Site | |
| Newcastle upon Tyne, United Kingdom, NE2 4HH | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01169844 History of Changes |
| Other Study ID Numbers: | CAIN457A2206E1 |
| Study First Received: | July 14, 2010 |
| Last Updated: | February 21, 2013 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Novartis:
|
Psoriatic arthritis IgG1K monoclonal antibody Interleukin -17A neutralizing |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013