Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00771030
First received: October 9, 2008
Last updated: January 20, 2011
Last verified: January 2011
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Purpose
This Phase 1b/2a study will evaluate safety, tolerability PK and PD of AMG 827 when administered in multiple SC and IV doses in patients with active rheumatoid arthritis in combination with a stable dose of DMARDs. Part A is dose escalation (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of AMG 827 from Part A.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: AMG 827 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Part B:Primary efficacy outcome is the bdACR Hybrid response in active or placebo groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety & tolerability: 1. treatment-emergent AE(s) 2. clinically significant changes in safety labs, PE, vital signs and 3. development of anti-AMG 827 antibodies. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | November 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arthritis, rheumatoid
Part A - Dose escalation Part B - Dose expansion
|
Drug: AMG 827
Five treatment dose levels plus placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female between 18 to 70 years of age, inclusive at the time of screening
- Diagnosed with active RA (class 1-3) for at least 6 months as determined by meeting ACR 1987 revised classification criteria.
- Additional Inclusion Criteria Apply
Exclusion Criteria:
- History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, liver disease, asthma, cardiovascular disease or hypertension
- Malignancy within 5 years (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)
- Presence of a serious or chronic infections
- Subject (male or female) is not willing to use highly effective contraception, defined as a double barrier method (ie, spermicidal jelly and condom, or condom and diaphragm) during treatment and up to EOS
- Additional Exclusion Criteria Apply
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00771030 History of Changes |
| Other Study ID Numbers: | 20070264 |
| Study First Received: | October 9, 2008 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Canada: Institutional Review Board Mexico: Ministry of Health United States: Food and Drug Administration United States: Institutional Review Board United States: Quorom Institutional Review Board Canada: Health Canada |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013