Safety and Efficacy of AMG 827 in Subjects With RA
This study has been terminated.
(Lack of efficacy for Brodalumab in Rheumatoid Arthritis (RA))
Information provided by (Responsible Party):
First received: January 28, 2010
Last updated: January 22, 2013
Last verified: January 2013
This is an extension study for subjects who participated in Protocol 20090061. All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.
Drug: AMG 827
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis
Primary Outcome Measures:
- To evaluate the safety of long-term exposure with AMG 827 is subjects with rheumatoid arthritis. [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20, 50, and 70 response [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 as measured by the change in Disease Activity Score 28 joint (DAS28) score [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 as measured by the proportion of subjects with DAS28<2.6 [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 as measured by the DAS28 score [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To evaluate the efficacy of AMG 827 as measured by the ACR individual components [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of treatment on patient-reported outcomes, including the Medical Outcomes Short Form-36 (SF-36), Medical Outcomes Study (MOS) Sleep Scale, and Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To determine the proportion of subjects who develop anti-AMG 827 anti-bodies [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
- To explore lipid profiles in subjects receiving AMG 827 [ Time Frame: 5 years of treatment with AMG 827 ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
Experimental: 210mg AMG 827
AMG 827 210mg at baseline, week 1, week2, and every 2 weeks thereafter
Drug: AMG 827
AMG 827 210 mg
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject has provided informed consent.
- Subject was randomized into study 20090061 and completed the week 16 evaluation.
- Negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) in subjects if clinically indicated (eg, known recent exposure) in the opinion of the investigator.
- Subject must test negative for Tuberculosis.
- Subject had any SAE reported during 20090061 that was considered to be related to IP.
- Subject is currently experiencing an infection of CTCAE grade 2 (if requiring oral antibiotics) or higher. Subject is ineligible until the infection is resolved in the opinion of the investigator.
- For subjects with > 4 weeks between the week 16 visit of 20090061 and the planned first IP dose in 20090402, subject has laboratory abnormalities at screening, including:
- Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); >1.5x upper limit of normal)
- Serum total bilirubin ≥1.5 mg/dL
- Hemoglobin < 11 g/dL
- Platelet count < 125,000 /mm3
- White blood cell count < 3,000 cells/mm3
- Absolute neutrophil count < 2000/mm3
- Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites)
- Subject has a significant concurrent medical conditions, including:
- Type 1 diabetes
- Poorly controlled type 2 diabetes (Hemoglobin A1c > 8.5)
- Symptomatic heart failure (New York Heart Association class II, III, or IV)
- Myocardial infarction within the last year
- Current or history of unstable angina pectoris within the last year
- Uncontrolled hypertension as defined by resting blood pressure > 150/90 mmHg prior to first IP dose (confirmed by a repeat assessment)
- Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- Major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus), with the exception of secondary Sjögren's syndrome
- Multiple sclerosis or any other demyelinating disease
- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)
- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject
- Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject's last study visit including the follow-up period.
- Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study and at least 40 days after the last dose (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier methods used by the man.
- Male subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study, plus an additional 16 weeks after the last dose (except for men who are surgically sterile or whose female partners are at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control include but are not limited to a condom in combination with hormonal birth control or barrier methods used by the woman.
- Male subject (including vasectomised males) with a pregnant female partner is not willing to use effective methods to ensure that an unborn child is not exposed to AMG 827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG 827 via semen include condoms or abstinence.
- Subject has used any of the following within 14 days prior to IP initiation
- Non-biologic disease-modifying anti-rheumatic drugs (DMARD) other than as allowed in 20090061
- Intra-articular, intramuscular, or intravenous corticosteroids, including adrenocorticotropic hormone
- Subject has used any of the following within 3 months prior to IP initiation
- Live vaccines
- Commercially available or experimental biologic DMARD except for AMG 827
- Subject has received gold therapy within 6 months prior to IP initiation.
- Subject received another investigational agent (other than AMG 827) or participated in an investigational device study subsequent to 20090061.
- Other investigational procedures are excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059448
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 28, 2010
||January 22, 2013
||Canada: Health Canada
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Mexico: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Bulgaria: Ministry of Health
Keywords provided by Amgen:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Connective Tissue Diseases
Immune System Diseases