Rheumatoid arthritis (RA)
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Major inclusion criteria are: • Subjects must have met all inclusion criteria and none of the exclusion criteria for study 20050168, were randomized and completed 24 weeks of the study. • Subjects must receive their first dose of IP within 18 days from their Week 24 visit in study 20050168. • Signed informed consent 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
Exclusion criteria: Major exclusion criteria are: • Uncontrolled or Significant concurrent medical events, in the opinion of the investigator, including: - Asthma - Malignancy - Liver disease - Renal disease - Hematologic abnormality - Diabetes mellitus - Cardiovascular disease - Hypertension - Chronic inflammatory disease or connective disease other than RA or secondary Sjogren’s syndrome - Infections (CTC grade 3) lasting > 2 consecutive weeks and/ or not responding to treatment in study 20050168 • 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 • Any physical and/or psychiatric condition that, in the opinion of the investigator, compromises the ability of the subject to give written informed consent • Any condition or disorder that, in the opinion of the investigator, would interfere with compliance with study procedures • Active substance abuse • Requiring or having a condition that, in the opinion of the investigator, may be expected to require strong narcotic analgesics (except hydrocodone, codeine, dextropropoxyphene, propoxyphene, or oxycodone) or morphine derived medication for analgesic relief at screening • Inability or unwillingness to self- administer (or by designated person) subcutaneous injections at home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoints are: • AE • Serious Adverse Event (SAE) • Serious infectious event (SIE) • Infectious event (IE) • Injection site reaction (ISR) • Change (by Common Toxicity Criteria grade) from baseline laboratory values • Infections in subjects with neutrophil counts <1.5 x 10’/pL • Opportunistic infections • Malignant neoplasm • Anti-AMG 108 antibodies (by immunoassay and cell-based bioassay) The secondary endpoints are:· • Change in mental and physical component summary ( MCS & PCS) of SF- 36 from baseline to weeks 24, 48, 96, 144 and End of Study • Change in HAQ- DI score from baseline to weeks 24, 48, 96, 144 and EOS • Change in EQ- 5D from baseline to weeks 24, 48 96, 144 and EOS • Change in work productivity measured by Work Productivity and Activity Impairment ( WPAI) Questionnaire from baseline to weeks 24, 48, 96, 144 and EOS • ACR20 response at week 24, 48, 96, 144 and EOS • ACR20 responses in subjects who are positive at least once or negative for anti- AMG 108 antibodies on both immunoassay and cell- based bioassay • AMG 108 trough concentration ( Cmin) at week 48, 96 and 144 The exploratory endpoints include the following: • ACR50 and ACR70 response at week 24, 48, 96, 144 and EOS • ACRn at week 24, 48, 96, 144 and EOS • AUC ACRn at week 24, 48, 96, 144 and EOS • Individual components of ACR response ( 20, 50 and 70) at week 24, 48, 96, 144 and EOS • DAS score and change in DAS 28 score from baseline ( EULAR28 response) at week 24, 48, 96, 144 and EOS • Time to onset of cardiovascular event from baseline ;Main Objective: The primary objective for this study is to assess long-term safety of AMG 108 (125mg, 250 mg) SC in subjects with RA previously enrolled in study 20050168 ;Secondary Objective: • To assess impact of concomitant immunosuppressives on long- term safety profile of AMG 108 • To assess impact of comorbidity on adverse event ( AE) profile of AMG 108 • To determine whether long- t | — |
Countries
Austria, Czech Republic, Estonia, France, Hungary, Ireland, Italy, Latvia, Netherlands, Sweden, United Kingdom
Outcome results
None listed