This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-005543-90-PL
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-11
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Men or women = 18 and = 80 years old
2.Subjects must be diagnosed with RA as determined by meeting 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
3.Duration of RA of at least 6 months
4.Active RA defined as = 6 swollen joints and = 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least one of the following at screening:
•erythrocyte sedimentation rate (ESR) = 28 mm/hr
•serum C-reactive protein (CRP) > 1.0 mg/dL
5.Subjects have had an inadequate response or intolerance to other DMARDs (which must include intolerance or inadequate response to one or more TNF inhibitor therapies).
6.Subjects must be taking methotrexate (MTX) for = 12 consecutive weeks and be on a stable dose of MTX 7.5 to 25 mg/week for = 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
7.Subject has no known history of active tuberculosis
8.Subject has a negative test for tuberculosis during screening defined as either:
•negative purified protein derivative (PPD) < 5 mm of induration at 48 to 72 hours after test is placed)
OR
•negative Quantiferon test
9.Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test
10.Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
•no symptoms per tuberculosis worksheet provided by the Sponsor, Amgen
•documented history of treatment with a TB prophylaxis regimen, with at least 4 weeks of prophylaxis therapy completed at the time of screening. If a subject has completed at least 4 weeks of prophylaxis therapy completed at a time of screening. If a subject has completed at least 4 weeks of prophylaxis therapy, and their regimen requires >4 weeks therapy, the subject must be deemed able and willing to complete the entire prophylaxis regimen in accordance with local guidance.
• no known exposure to a case of active tuberculosis after most recent prophylaxis
• no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.History of prosthetic or native joint infection
2.Active infection or history of infections as follows:
•any active infection for which systemic anti-infectives were used within 4 weeks prior to first dose of IP
•a serious infection, defined as requiring hospitalization or IV anti infectives within 8 weeks prior to the first dose of IP
•recurrent or chronic infections or other active infection that, in the opinion of the Investigator, might cause this study to be detrimental to the subject
3.Known history of human immunodeficiency virus
4.Hepatitis B surface antigen (HbsAg), Hepatitis B core antibody (anti-HBc) positivity at screening (unless documentation of hepatitis B virus immunization), or Hepatitis C virus (HCV) antibody positivity at screening
5.Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including severe heart failure (New York Heart Association [NYHA] class IV), or severe uncontrolled cardiac disease, renal disease, or liver disease
6.Malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma
7.History of neurologic symptoms suggestive of central nervous system demyelinating disease
8.Laboratory abnormalities at screening, including any of the following:
•hemoglobin < 9 g/dL
•platelet count < 100,000/mm3
•white blood cell count < 3,000 cells/mm3
•aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 2.0 x the upper limit of normal
•creatinine clearance < 50 mL/min (Cockroft-Gault formula)
9.Use of commercially available or investigational biologic therapies for RA as follows:
•anakinra, etanercept within 1 month prior to first dose of IP
•infliximab, abatacept, tocilizumab, golimumab, certolizumab, adalimumab within 3 months prior to first dose of investigational product
•other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of investigational product
10.Live vaccines within 28 days prior to the first dose of investigational product
11.Previous receipt of rituximab or a biosimilar of rituximab, or ocrelizumab
12.For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 12 months after the last dose of investigational product
13.Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) while on study and for 12 months after the last dose of investigational product.

Study & Design

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