Phase 3
Completed N=650
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Source: ClinicalTrials.gov NCT02222493 ↗Enrolled (actual)
650
Serious AEs
4.4%
Results posted
Sep 2017
Primary outcomePrimary: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 — 198; 207 participants
◆ Published Evidence
Established
59citations · ~7 / year
A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.
Summary
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
Linked Publications (5)
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A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy.
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Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54.
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Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial.
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Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active 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 Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 |
198; 207 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1 |
105; 121; 170; 190; 187; 201 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 |
206; 101; 110; 199; 98; 99 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 |
199; 89; 103; 199; 87; 98 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1 |
24; 24; 72; 59; 88; 80 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2 |
132; 58; 75; 135; 55; 63 | — |
| SECONDARY Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 |
132; 59; 71; 142; 61; 67 | — |
| SECONDARY Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 |
5.950; 5.983; -1.213; -1.241; -1.596; -1.605 | — |
| SECONDARY Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 |
3.765; 3.819; 3.781; -0.181; 0.036; -0.059 | — |
| SECONDARY Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 |
3.386; 3.561; 3.594; -0.072; -0.004; -0.154 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 |
2; 3; 10; 11; 12; 10 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 |
29; 15; 8; 39; 15; 7 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 |
46; 19; 20; 50; 18; 19 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 |
24; 34; 172; 161; 121; 129 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 |
110; 51; 49; 132; 62; 66 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 |
122; 50; 57; 102; 56; 54 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 |
185; 176; 16; 20; 81; 75 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 |
103; 48; 54; 13; 11; 4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 |
73; 38; 37; 3; 3; 6 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 |
34; 34; 1; 6; 2; 1 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 |
17; 10; 6; 3; 3; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 |
4; 3; 7; 1; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 1 |
245; 237 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 2 |
154; 83; 63 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities: Period 3 |
127; 72; 61 | — |
| SECONDARY Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 |
24.7; 25.8; -5.9; -7.5; -9.5; -10.4 | — |
| SECONDARY Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 |
10.2; 10.2; 9.1; -1.3; -0.5; -1.0 | — |
| SECONDARY Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 |
7.5; 7.5; 7.4; -0.7; 0.3; -0.8 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1 |
63.514; 63.098; -15.724; -15.360; -21.609; -20.552 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2 |
33.137; 33.331; 32.559; -0.014; 1.440; -0.705 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3 |
30.395; 31.659; 31.225; -0.025; 0.276; -1.790 | — |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 |
25.916; 25.366; -17.183; -16.140; -15.555; -13.407 | — |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 |
12.970; 14.427; 10.847; 0.496; 1.805; 0.093 | — |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 |
13.112; 16.096; 11.985; -0.635; -3.648; -0.541 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 |
157; 167; 124; 143 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 |
146; 86; 83; 118; 73; 65 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 |
119; 66; 72; 105; 58; 60 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 1 |
1635; 656.2; 65310; 62220; 17350; 16690 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 2 |
1801; 1083; 1819; 1855; 1208; 1620 | — |
| SECONDARY Serum Concentration Versus Time Summary: Period 3 |
2078; 1823; 1734; 1913; 1388; 1572 | — |
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 10 mg/L.
Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.
Exclusion Criteria
Evidence of untreated or inadequately treated latent or active TB.
Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT02222493) 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.