Phase 3
Completed N=445
A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT04230213 ↗
Enrolled (actual)
445
Serious AEs
2.8%
Results posted
Aug 2022
Primary outcomePrimary: Maximum Observed Serum Concentration (Cmax) of Adalimumab — 9.156; 8.974 Micrograms per milliliter
◆ Published Evidence
Emerging
14citations · ~5 / year
Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study.
Summary
The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.
Linked Publications
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Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Adalimumab |
9.156; 8.974 | — |
| PRIMARY Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab |
2472; 2365 | — |
| SECONDARY Time to Reach Cmax (Tmax) of Adalimumab |
71.80; 72.00 | — |
| SECONDARY Average Serum Concentration (Cav) of Adalimumab |
7.357; 7.040 | — |
| SECONDARY Apparent Clearance (CL/F) of Serum Adalimumab |
16.19; 16.91 | — |
| SECONDARY Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab |
0.03102; 0.05703; 6.999; 6.675; 7.763; 7.374 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1 |
107; 13; 31 | — |
| SECONDARY Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond |
82; 62; 3; 8; 19; 10 | — |
| SECONDARY Number of Participants With Grade 3 or Higher TEAEs: TP1 |
14 | — |
| SECONDARY Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond |
5; 8 | — |
| SECONDARY Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1 |
3; 12 | — |
| SECONDARY Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond |
0; 3; 8; 9 | — |
| SECONDARY Number of Participants With TEAEs of Special Interest: TP2 and Beyond |
58; 47 | — |
| SECONDARY Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1 |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1 |
4; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1 |
10; 6 | — |
| SECONDARY Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond |
20; 16; 1; 3 | — |
| SECONDARY Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1 |
0; 6 | — |
| SECONDARY Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond |
0; 0; 3; 4 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: TP1 |
134 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: TP2 and Beyond |
71; 83 | — |
| SECONDARY Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond |
198; 190; 207; 201; 209; 205 | — |
| SECONDARY Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond |
169; 174; 202; 196; 195; 198 | — |
| SECONDARY Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond |
208; 207; 2; 1; 1; 0 | — |
| SECONDARY Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 (EOT/ ET) |
125.7; 125.9; 126.0; 126.2; 0.3; 0.4 | — |
| SECONDARY Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET) |
73.6; 73.2; 73.6; 73.1; 0.1; -0.2 | — |
| SECONDARY Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET) |
36.5; 36.5; 36.4; 36.4; -0.0; -0.0 | — |
| SECONDARY Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET) |
16.6; 16.6; 16.5; 16.6; -0.1; -0.0 | — |
| SECONDARY Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive |
55; 59; 22; 19; 88; 97 | — |
| SECONDARY Mean ADA Titers |
0.830; 0.880; 1.385; 1.546; 1.570; 1.784 | — |
| SECONDARY Mean NAb Titers |
0.712; 0.718; 0.467; 0.443; 0.488; 0.405 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
- Moderately to severely active RA based on local standard of care.
Exclusion Criteria
-Evidence of untreated or inadequately treated latent or active TB.
Data sourced from ClinicalTrials.gov (NCT04230213) 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.