Phase 3
Completed N=597
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Source: ClinicalTrials.gov NCT02480153 ↗Enrolled (actual)
597
Serious AEs
3.6%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 — 68.35; 71.33 percentage of participants
◆ Published Evidence
Established
53citations · ~11 / year
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
Summary
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.
In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.
Linked Publications (5)
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Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
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Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293.
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Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira®) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial.
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Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis.
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Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 |
68.35; 71.33 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1 |
93; 96; 154; 157; 182; 179 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2 |
245; 114; 116; 245; 111; 116 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3 |
229; 106; 112; 447; 230; 105 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1 |
25; 18; 53; 43; 82; 82 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2 |
175; 76; 86; 169; 67; 82 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3 |
177; 74; 96; 347; 175; 78 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1 |
2; 6; 11; 11; 24; 26 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2 |
88; 41; 52; 96; 41; 49 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3 |
103; 42; 58; 203; 101; 42 | — |
| SECONDARY Change From Baseline in Tender Joint Count: Period 1 |
24.3; 26.7; -7.5; -7.1; -10.2; -10.7 | — |
| SECONDARY Change From Baseline in Tender Joint Count: Period 2 |
23.7; 26.8; 25.5; -18.4; -20.1; -19.3 | — |
| SECONDARY Change From Baseline in Tender Joint Count: Period 3 |
23.8; 26.5; 25.4; 24.9; -19.3; -21.2 | — |
| SECONDARY Change From Baseline in Swollen Joint Count: Period 1 |
15.4; 17.0; -5.7; -6.1; -7.7; -8.2 | — |
| SECONDARY Change From Baseline in Swollen Joint Count: Period 2 |
15.1; 17.1; 17.0; -12.2; -13.6; -14.3 | — |
| SECONDARY Change From Baseline in Swollen Joint Count: Period 3 |
15.0; 17.3; 16.8; 16.0; -12.8; -14.4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1 |
65.0; 66.7; -20.7; -20.5; -28.9; -29.0 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2 |
64.9; 66.3; 67.0; -47.7; -45.5; -49.2 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3 |
65.4; 66.4; 67.0; 66.1; -48.9; -48.5 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1 |
63.7; 65.9; -13.1; -13.9; -18.5; -17.4 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2 |
63.5; 65.6; 64.4; -35.4; -32.4; -36.0 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3 |
63.5; 66.3; 64.5; 64.4; -38.1; -37.3 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1 |
64.4; 68.1; -13.8; -16.3; -19.7; -21.2 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2 |
64.2; 67.5; 67.8; -36.3; -35.3; -38.8 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3 |
64.1; 67.5; 68.1; 65.9; -38.3; -39.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1 |
1.519; 1.673; -0.254; -0.288; -0.338; -0.375 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2 |
1.514; 1.639; 1.666; -0.658; -0.652; -0.723 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3 |
1.528; 1.632; 1.684; 1.592; -0.719; -0.737 | — |
| SECONDARY Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1 |
21.3; 22.8; -12.6; -13.4; -11.5; -13.1 | — |
| SECONDARY Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2 |
21.2; 22.0; 22.3; -11.3; -11.2; -15.8 | — |
| SECONDARY Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3 |
20.4; 22.3; 22.7; 21.4; -10.7; -11.9 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1 |
5.9; 6.1; -1.2; -1.1; -1.5; -1.6 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2 |
5.9; 6.1; 6.0; -2.7; -2.7; -3.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3 |
5.9; 6.1; 6.0; 6.0; -2.9; -2.9 | — |
| SECONDARY Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1 |
18; 20; 161; 136; 110; 133 | — |
| SECONDARY Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2 |
161; 67; 80; 109; 53; 45 | — |
| SECONDARY Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3 |
169; 60; 85; 314; 80; 53 | — |
| SECONDARY Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1 |
0; 0; 9; 8; 20; 17 | — |
| SECONDARY Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2 |
86; 41; 58; 96; 42; 51 | — |
| SECONDARY Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3 |
107; 39; 59; 205; 111; 46 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1 |
2; 3; 3; 5; 14; 11 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2 |
38; 26; 19; 50; 26; 27 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3 |
53; 27; 34; 114; 63; 28 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 1 |
104.8; 187.3; 3756; 3488; 3349; 3025 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 2 |
8346; 7058; 7557; 8314; 6831; 7626 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 3 |
7539; 6298; 8157; 7398; 7402; 6261 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1 |
132; 151; 41; 42 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2 |
134; 73; 61; 46; 18; 16 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3 |
119; 65; 59; 243; 54; 30 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 |
143; 143; 12; 13; 55; 69 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 |
123; 60; 51; 4; 6; 3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 |
110; 61; 47; 218; 9; 9 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 1 |
181; 180 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 2 |
171; 85; 73 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 3 |
176; 77; 77; 330 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
- Hs-CRP equal or greater than 8 mg/L.
- Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
Exclusion Criteria
- Evidence of untreated or inadequately treated latent or active TB.
- Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
- History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
- May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
- Any second DMARD must be washed out prior to the first study dose.
Data sourced from ClinicalTrials.gov (NCT02480153) 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.