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Phase 3 Completed N=311 Randomized Quadruple-blind Treatment

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

Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02792699 ↗
Enrolled (actual)
311
Serious AEs
6.1%
Results posted
Oct 2019
Primary outcomePrimary: Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose — 149398; 172463; 158529 h*µg/mL
◆ Published Evidence
Emerging
15citations · ~3 / year
A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.
Clinical pharmacology in drug development · 2020 · Open access · Likely link

Summary

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on 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 RA. This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Linked Publications

  • A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis.
    Clinical pharmacology in drug development · 2020 · 15 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose
149398; 172463; 158529
PRIMARY
Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose
361; 394; 372
SECONDARY
Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 Days Postdose (AUC0-14day)
41445; 45161; 43291
SECONDARY
Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)
146369; 166995; 155240
SECONDARY
Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose
298; 321; 304
SECONDARY
Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose
4.50; 4.67; 4.68; 3.57; 3.67; 4.12
SECONDARY
Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)
5.95; 8.52; 6.76
SECONDARY
Terminal Elimination Half-life (t1/2)
335.62; 375.26; 334.57
SECONDARY
Terminal Elimination Rate Constant (λz)
0.00205; 0.00187; 0.00205
SECONDARY
Clearance (CL)
0.01339; 0.01160; 0.01262
SECONDARY
Mean Residence Time (MRT)
549; 592; 557
SECONDARY
Percent of AUC Extrapolation (AUC%Extrap)
1.91; 2.62; 2.06
SECONDARY
AUC0-12 wk/AUCinf
0.97; 0.96; 0.97
SECONDARY
Change From Baseline in Disease Activity Score 28-CRP at Week 24
-2.006; -2.116; -1.936; -2.026
SECONDARY
Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
-1.674; -1.738; -1.527; -1.746; -2.248; -2.016
SECONDARY
Percentage of Participants With an ACR20 Response
56.4; 60.0; 54.6; 67.6; 73.3; 63.3
SECONDARY
Percentage of Participants With an ACR50 Response
26.7; 29.3; 24.7; 36.3; 47.5; 32.7
SECONDARY
Percentage of Participants With an ACR70 Response
6.9; 12.0; 9.3; 12.9; 19.8; 16.3
SECONDARY
Hybrid ACR
32.631; 34.630; 32.086; 36.604; 44.828; 38.664
SECONDARY
Percentage of Participants With Complete Depletion in CD19+ Cell Count on Day 3
94.8; 96.9; 92.8
SECONDARY
Duration of Complete Depletion in CD19+ Cell Count
NA; NA; NA
SECONDARY
Number of Participants With Adverse Events After the First Dose
52; 44; 44; 4; 6; 4
SECONDARY
Number of Participants Who Developed Anti-drug Antibodies
14; 13; 20; 8; 4; 10
SECONDARY
Number of Participants With Clinically Significant Laboratory Findings
0; 0; 1; 64; 54; 52

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02792699) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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