Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02937701
• Date of registration: 30/08/2016
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
• Scientific title: A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: October 10, 2016
• Target sample size: 558
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02937701
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Czechia, Germany, Hungary, Poland, Spain, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject (man or woman) is = 18 and = 80 years old.

- Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010
American College of Rheumatology (ACR)/European League Against Rheumatism
classification criteria for RA.

- Subject has RA duration of at least 3 months.

- Subject has 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 1 of the following at screening:

- erythrocyte sedimentation rate = 28 mm/hr

- serum C-reactive protein > 1.0 mg/dL

- Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at
screening.

- Subject has taken methotrexate (MTX) for = 12 consecutive weeks and is on a stable
dose of oral or subcutaneous MTX 7.5 to 25 mg/week for = 8 weeks before receiving the
investigational product and is willing to remain on a stable dose throughout the
study.

- For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency
analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be
stable for = 2 weeks before screening.

- For a subject on oral corticosteroids (= 10 mg prednisone or equivalent), the dose
should be stable for = 4 weeks before screening.

- Subject has no known history of active tuberculosis.

- Subject has a negative test for tuberculosis during screening defined as either:

- negative purified protein derivative (PPD) defined as < 5 mm of induration at 48
to 72 hours after test is placed OR

- negative Quantiferon test

- Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is
allowed with a negative Quantiferon test.

- Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin
vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed
if they have all of the following:

- no symptoms of tuberculosis according to the worksheet provided by the sponsor,
Amgen Inc.

- documented history of adequate prophylaxis initiation before receiving
investigational product in accordance with local recommendations

- no known exposure to a case of active tuberculosis after most recent prophylaxis

Exclusion Criteria:

- Subject has a history of prosthetic or native joint infection.

- Subject has an active infection or history of infections as follows:

- any active infection for which systemic anti-infectives were used within 28 days
before first dose of investigational product

- a serious infection, defined as requiring hospitalization or intravenous (IV)
anti-infective(s) within 8 weeks before the first dose of investigational product

- 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

- Subject has a positive blood test for human immunodeficiency virus (HIV).

- Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or
hepatitis C virus antibody result at screening.

- Subject has uncontrolled, clinically significant systemic disease such as diabetes
mellitus, cardiovascular disease including moderate or severe heart failure (New York
Heart Association Class III/IV), renal disease, liver disease, or hypertension.

- Subject had a malignancy within 5 years EXCEPT for treated and considered cured
cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast
ductal carcinoma.

- Subject has a history of neurologic symptoms suggestive of central or peripheral
nervous system demyelinating disease.

- Subject has a major chronic inflammatory disease or connective tissue disease other
than RA, with the exception of secondary Sjögren's syndrome.

- Subject has a concurrent medical condition that, in the opinion of the investigator,
could cause this study to be detrimental to the subject.

- Subject has laboratory abnormalities at screening, including any of the following:

- hemoglobin < 9 g/dL

- platelet count < 100 000/mm³

- white blood cell count < 3 000/mm³

- aspartate aminotransferase and/or alanine aminotransferase = 2.0 x the upper
limit of normal

- creatinine clearance < 50 mL/min (Cockroft-Gault formula)

- any other laboratory abnormality, that, in the opinion of the investigator, will
prevent the subject from completing the study or will interfere with the
interpretation of the study results.

- Subject has used commercially available or investigational biologic therapies for RA
as follows:

- anakinra, etanercept within 1 month before the first dose of investigational
product

- abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 3 months
before the first dose of investigational product

- other experimental or commercially available biologic therapies for RA within 3
months or 5 half-lives (whichever is longer) before the first dose of
investigational product

- rituximab within 9 months before the investigational product along with evidence
of incomplete B cell recovery

- Subject has received live vaccines within 28 days before the first dose of
investigational product or plans to receive live vaccines during the course of the
study.

- Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab.

- Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in
the study and for 6 months after the last dose of investigational product.

- Women of childbearing potential (ie, neither surgically sterile nor postmenopausal)
and do not agree to use adequate contraception (eg, true abstinence, sterilization,
birth control pills, Depo-Provera® [medroxyprogesterone] injections, or contraceptive
implants) while on study and for 6 months after the last dose of investigational
product.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Biological: ABP 710

Biological: Infliximab

Primary Outcome(s)

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 [Time Frame: Baseline and week 22]

Secondary Outcome(s)

Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]

Percentage of Participants With an ACR70 Response Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]

Percentage of Participants With an ACR50 Response Through Week 22 [Time Frame: Baseline and weeks 2, 6, 14, and 22]

Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]

Percentage of Participants With an ACR20 Response Through Week 14 [Time Frame: Baseline and weeks 2, 6, and 14]

Percentage of Participants With an ACR50 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]

Percentage of Participants With an ACR20 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]

Percentage of Participants With an ACR70 Response After Week 22 [Time Frame: Baseline and weeks 30, 34, 38, 46, and 50]

Secondary ID(s)

20140111

2014-004704-29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02937701