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Safety and Efficacy of AMG 827 in Subjects With RA

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ClinicalTrials.gov Identifier: NCT01059448
Recruitment Status : Terminated (Lack of efficacy for Brodalumab in Rheumatoid Arthritis (RA))
First Posted : February 1, 2010
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AMG 827 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 210mg AMG 827
AMG 827 210mg at baseline, week 1, week2, and every 2 weeks thereafter
Drug: AMG 827
AMG 827 210 mg




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. To evaluate the efficacy of AMG 827 as measured by the DAS28 score [ Time Frame: 5 years of treatment with AMG 827 ]
  6. To evaluate the efficacy of AMG 827 as measured by the ACR individual components [ Time Frame: 5 years of treatment with AMG 827 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine the proportion of subjects who develop anti-AMG 827 anti-bodies [ Time Frame: 5 years of treatment with AMG 827 ]
  3. To explore lipid profiles in subjects receiving AMG 827 [ Time Frame: 5 years of treatment with AMG 827 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059448


Locations
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United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85258
Research Site
Tucson, Arizona, United States, 85711
United States, California
Research Site
La Jolla, California, United States, 92037
Research Site
Victorville, California, United States, 92395
United States, Florida
Research Site
Sarasota, Florida, United States, 34239
United States, Illinois
Research Site
Rock Island, Illinois, United States, 61201
Research Site
Springfield, Illinois, United States, 62704
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40504
United States, Michigan
Research Site
Grand Rapids, Michigan, United States, 49546
Research Site
Lansing, Michigan, United States, 48910
United States, New Jersey
Research Site
Freehold, New Jersey, United States, 07728
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Bulgaria
Research Site
Sofia, Bulgaria, 1612
Research Site
Sofia, Bulgaria, 1709
Research Site
Veliko Tarnovo, Bulgaria, 5000
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H2L 1S6
Czech Republic
Research Site
Praha 11, Czech Republic, 148 00
Research Site
Praha 4, Czech Republic, 140 59
Latvia
Research Site
Bauska, Latvia, 3901
Research Site
Daugavpils, Latvia, 5417
Research Site
Liepaja, Latvia, 3400
Research Site
Riga, Latvia, 1002
Research Site
Riga, Latvia, 1006
Mexico
Research Site
Tijuana, Baja Calif, Mexico, 22010
Research Site
Mexico City, Distrito F, Mexico, 06700
Research Site
Mexico City, Distrito F, Mexico, 14050
Research Site
Guadalajara, Jalisco, Mexico, 44690
Research Site
Morelia, Michoacán, Mexico, 58070
Research Site
San Luis Potosi, San Luis P, Mexico, 78240
Poland
Research Site
Bialystok, Poland, 15-351
Research Site
Bialystok, Poland, 15-461
Research Site
Lublin, Poland, 20-607
Research Site
Poznan, Poland, 60-356
Research Site
ToruÅ", Poland, 87-100
Research Site
Warszawa, Poland, 02-118
Research Site
Wroclaw, Poland, 50-044
Research Site
Wroclaw, Poland, 50-088
Research Site
Zyrardow, Poland, 96-300
United Kingdom
Research Site
Merseyside, United Kingdom, L49 5PE
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01059448    
Other Study ID Numbers: 20090402
First Posted: February 1, 2010    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: July 2015
Keywords provided by Amgen:
Amgen
RA
AMG 827
20090061
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Brodalumab
Dermatologic Agents