Safety and Efficacy of AMG 827 in Subjects With RA

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989). All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.

Key facts

Study ID: NCT01059448
Run by: Amgen
People needed: 211
Starts: 2010-06-03
Expected to finish: 2011-04-05
Last updated by the study team: 2022-02-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Scottsdale, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — La Jolla, California, United States
Research Site — Victorville, California, United States
Research Site — Sarasota, Florida, United States
Research Site — Rock Island, Illinois, United States
Research Site — Springfield, Illinois, United States
Research Site — Lexington, Kentucky, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Lansing, Michigan, United States
Research Site — Freehold, New Jersey, United States
Research Site — Portland, Oregon, United States
Research Site — Duncansville, Pennsylvania, United States
Research Site — Tacoma, Washington, United States
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Veliko Tarnovo, Bulgaria
Research Site — Winnipeg, Manitoba, Canada
Research Site — St. John's, Newfoundland and Labrador, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Prague, Czechia
Research Site — Prague, Czechia
Research Site — Bauska, Latvia
Research Site — Daugavpils, Latvia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.