Clinical trial NCT01059448: Safety and Efficacy of AMG 827 in Subjects With RA
Official title: A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Amgen
RA
AMG 827
20090061
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Number of Participants With a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Week 52 of study 20090402
measure: Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: Number of Participants Who Achieved an ACR 50 Response
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: Number of Participants Who Achieved an ACR 70 Response
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: Number of Participants With a DAS28 Score < 2.6
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: DAS28 Score at All Measured Timepoints
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: CRP Levels at All Measured Timepoints
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
measure: ESR at All Measured Timepoints
timeFrame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: La Jolla
country: United States
facility: Research Site
state: California
city: Victorville
country: United States
facility: Research Site
state: California
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Rock Island
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Grand Rapids
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Praha 11
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Bauska
country: Latvia
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Tijuana
country: Mexico
facility: Research Site
state: Baja Calif
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito F
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito F
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Morelia
country: Mexico
facility: Research Site
state: MichoacÃ¡n
city: San Luis Potosi
country: Mexico
facility: Research Site
state: San Luis P
city: Bialystok
country: Poland
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: ToruÅ"
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zyrardow
country: Poland
facility: Research Site
city: Merseyside
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: