Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02792699
• Date of registration: 25/04/2016
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
• Scientific title: A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: May 17, 2016
• Target sample size: 311
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02792699
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Estonia, Germany, Hungary, Poland, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women = 18 and = 80 years old

- Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before
baseline

- Active RA defined as = 6 swollen joints and = 6 tender 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

- Subjects must be taking methotrexate (MTX) for = 12 consecutive weeks and 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

- Subject has no known history of active tuberculosis

Exclusion Criteria:

- Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

- Major chronic inflammatory disease or connective tissue disease other than RA, with
the exception of secondary Sjögren's syndrome

- 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 within 3 months prior
to first dose of IP

- other experimental or commercially available biologic therapies for RA within 3
months or 5 half-lives (whichever is longer) prior to first dose of IP

- Previous receipt of rituximab or a biosimilar of rituximab

Other Inclusion/Exclusion criteria may apply



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

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: ABP 798

Drug: Rituximab (EU)

Drug: Rituximab (US)

Primary Outcome(s)

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose [Time Frame: Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.]

Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose [Time Frame: Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.]

Secondary Outcome(s)

Change From Baseline in Disease Activity Score 28-CRP at Week 24 [Time Frame: Baseline and Week 24]

Percentage of Participants With an ACR50 Response [Time Frame: Baseline and Weeks 8, 12, 24, 40, and 48]

Number of Participants With Adverse Events After the First Dose [Time Frame: From day 1 until the first infusion of the second dose (week 24)]

Percentage of Participants With Complete Depletion in CD19+ Cell Count on Day 3 [Time Frame: Day 3]

Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Percentage of Participants With an ACR70 Response [Time Frame: Baseline and Weeks 8, 12, 24, 40, and 48]

Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48 [Time Frame: Baseline and weeks 8, 12, 40, and 48]

Clearance (CL) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Mean Residence Time (MRT) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast) [Time Frame: Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 Days Postdose (AUC0-14day) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.]

Hybrid ACR [Time Frame: Baseline and weeks 8, 12, 24, 40, and 48]

Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.]

Number of Participants With Clinically Significant Laboratory Findings [Time Frame: Day 1 through the end of study (48 weeks).]

Percent of AUC Extrapolation (AUC%Extrap) [Time Frame: Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hour postdose, and at days 29, 57, and 85 (week 12).]

Terminal Elimination Rate Constant (?z) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57 and 85 (week 12).]

Percentage of Participants With an ACR20 Response [Time Frame: Baseline and Weeks 8, 12, 24, 40, and 48]

Terminal Elimination Half-life (t1/2) [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

AUC0-12 wk/AUCinf [Time Frame: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).]

Duration of Complete Depletion in CD19+ Cell Count [Time Frame: CD19+ cell count was assessed at baseline, days 2, 3, weeks 4, 24, and 48]

Number of Participants Who Developed Anti-drug Antibodies [Time Frame: Day 1 through the end of study (48 weeks).]

Secondary ID(s)

20130108

2013-005543-90

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02792699