Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02114931
• Date of registration: 11/04/2014
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
• Scientific title: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: April 2014
• Target sample size: 467
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02114931
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Romania, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Amgen MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26
visit

Exclusion Criteria:

- Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the
20120262 study that could cause extension treatment to be detrimental

- Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26
visit of study 20120262

- Current infection requiring the use of oral or intravenous antibiotics

Other Inclusion/Exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 81 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Biological: ABP 501

Primary Outcome(s)

Percentage of Participants Who Developed Antibodies to ABP 501 [Time Frame: Up to week 72]

Number of Participants With Grade = 3 Hematology and Chemistry Laboratory Results [Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks]

Number of Participants With Adverse Events [Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks]

Secondary Outcome(s)

Percentage of Participants With an American College of Rheumatology (ACR) 20 Response [Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70]

Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) [Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70]

Secondary ID(s)

20130258

2013-004654-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02114931