A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108

• Conditions: Rheumatoid arthritis (RA)

• Registration Number: EUCTR2005-003558-83-CZ
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 784

Inclusion Criteria

Major inclusion criteria are:
• Subjects must be diagnosed with RA as determined by meeting 1987 American College of Rheumatology ( ACR) classification criteria.
• Active RA defined as = 6 swollen joints and = 6 tender/painful joints and at least one of the following: Erythrocyte sedimentation rate (ESR) = 28 mm/hr, C-reactive protein (CRP) > 2.0 mg/dL, or duration of morning stiffness = 45 minutes at time of screening
• Duration of RA for at least 6 months
• Men or women =18 and = 70 years old
• Subjects must be taking MTX consecutively for =12 weeks and on a stable dose of oral or SC MTX at 15-25 mg weekly for =4 weeks at screening. A lower MTX dose is acceptable if it is the highest tolerated dose (toxicity documentation required)
• If using non-steroidal anti-inflammatory drugs (NSAIDs) or oral corticosteroids, subjects must be on stable use of NSAIDs or oral corticosteroids (=10 mg prednisone or equivalent) =4 weeks prior to screening
• Before any study-specific procedure, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Major exclusion criteria are:
• Previous receipt of commercial or experimental biologic therapies including AMG 108, anakinra (Kineret®), AMG 719, soluble IL-1 type II receptor, etanercept, infliximab, adalimumab, onercept, pegsunercept, abatacept, or rituximab or any other biologic therapy used to treat an inflammatory disease
• Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, cardiovascular disease or hypertension
• Uncontrolled or clinically significant asthma
• Malignancy within 5 years (except successfully treated in-situ cervical cancer or squamous or basal cell carcinoma)
• Presence of a serious infection, defined as requiring hospitalization or recurrent, acute or chronic infections within 8 weeks before screening
• Prior or current history of Mycobacterium tuberculosis infection or exposure
• Class IV RA (Hochberg 1992) according to ACR revised response criteria
• Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
• Felty’s syndrome
• Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren’s syndrome
• Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) or HIV
• Uncontrolled, clinically significant history of hematologic abnormality or white blood cell count <3.0 x103/µL, absolute neutrophil count (ANC) of < 2.5 x 103/µL, or platelet count of < 125 x 103/µL at screening
• Uncontrolled, clinically significant history of liver disease or elevated aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 x upper limit of
normal (ULN) at screening
• Uncontrolled, clinically significant history of renal disease or elevated serum creatinine > 1.5 x upper limit of normal at screening
• Laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
• Intra-articular (IA) or systemic corticosteroid injections within 4 weeks of screening
• Any DMARD other than MTX within 6 weeks of screening
• Cyclophosphamide within 6 months of screening
• Received live vaccines within 3 months of first dose of investigational product
• Any investigational therapy within 4 weeks of screening
• Pregnant or nursing
• Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not using adequate contraception
• Known sensitivity to mammalian cell derived drug products
• Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
• Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
• Active substance abuse (within 24 weeks of screening)
• Requiring or having a condition that may be expected to require strong narcotic analgesics (except hydrocodone, codeine, dextropropoxyphene, propoxyphene, or
oxycodone) or morphine derived medication for analgesic relief at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified