Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
211 participants
INTERVENTIONAL
2010-06-03
2011-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Placebo Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK). Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
AMG 827
AMG 827 210 mg
70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
AMG 827
AMG 827 210 mg
140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK
Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
AMG 827
AMG 827 210 mg
210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK
Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
AMG 827
AMG 827 210 mg
Interventions
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AMG 827
AMG 827 210 mg
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Leflunomide
* 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.
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Research Site
Liepāja, , Latvia
Research Site
Riga, , Latvia
Research Site
Riga, , Latvia
Research Site
Tijuana, Baja Calif, Mexico
Research Site
Mexico City, Distrito F, Mexico
Research Site
Mexico City, Distrito F, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Morelia, Michoacán, Mexico
Research Site
San Luis Potosí City, San Luis P, Mexico
Research Site
Bialystok, , Poland
Research Site
Bialystok, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
ToruÅ", , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Żyrardów, , Poland
Research Site
Merseyside, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090402
Identifier Type: -
Identifier Source: org_study_id
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