AMG 827 in Subjects With Psoriatic Arthritis
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01516957
First received: August 18, 2011
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriatic Arthritis |
Drug: AMG 827 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis. |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
- To evaluate the safety of AMG 827 in psoriatic arthritis as measured by development of antibodies to AMG 827 [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
- To evaluate the safety of AMG 827 in psoriatic arthritis as measured by number of subjects with AE [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 168 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMG 827 SC 140 mg
140 mg AMG 827
|
Drug: AMG 827
140 mg AMG 827 SC (subcutaneous)
|
|
Placebo Comparator: Placebo SC
Placebo
|
Drug: Placebo
Placebo SC (subcutaneous)
|
|
Experimental: AMG 827 SC 280 mg
280 mg AMG 827
|
Drug: AMG 827
280 mg AMG 827 SC (subcutaneous)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months
- Subject has ≥ 3 tender and ≥ 3 swollen joints
Exclusion Criteria:
- Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days
- Use of anti-TNF therapy within 2 months
- Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months
- Prior use of rituximab
- Prior use of anti-IL-17 biologic therapy, including AMG 827
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516957
Show 31 Study Locations
Show 31 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01516957 History of Changes |
| Other Study ID Numbers: | 20101227 |
| Study First Received: | August 18, 2011 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Psoriatic Arthritis IL-17 AMG 827 |
AMG827 Musculoskeletal Disease Spondylarthropathy |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis |
Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013