A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

• ClinicalTrials.gov Identifier: NCT02222493
• Recruitment Status: Completed
• First Posted: August 21, 2014
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: PF-06438179; Biological: Infliximab	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
• Actual Study Start Date: August 26, 2014
• Actual Primary Completion Date: June 29, 2016
• Actual Study Completion Date: June 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: PF-06438179	Biological: PF-06438179; PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.; Other Name: Infliximab-Pfizer
Active Comparator: Infliximab	Biological: Infliximab; Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.; Other Name: Infliximab-EU, Remicade

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1 [ Time Frame: Week 14 ]
   ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).

Secondary Outcome Measures :

1. 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 [ Time Frame: Week 2, 4, 6, 12, 22 and 30 (pre-dose) ]
   ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
2. Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2 [ Time Frame: Week 38, 46 and 54 (pre-dose) ]
   ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
3. Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3 [ Time Frame: Week 62, 70 and 78 ]
   ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
4. 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 [ Time Frame: Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose) ]
   ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
5. 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 [ Time Frame: Week 38, 46 and 54 (pre-dose) ]
   ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
6. Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3 [ Time Frame: Week 62, 70 and 78 ]
   ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
7. 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 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30 ]
   DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
8. Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2 [ Time Frame: Baseline (Week 30 pre-dose), Week 38, 46 and 54 ]
   DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
9. Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3 [ Time Frame: Baseline (Week 54 pre-dose), Week 62, 70 and 78 ]
   DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
10. Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1 [ Time Frame: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose) ]
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
11. Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2 [ Time Frame: Week 38, 46 and 54 (pre-dose) ]
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
12. Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3 [ Time Frame: Week 62, 70 and 78 ]
    ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
13. Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1 [ Time Frame: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose) ]
    EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
14. Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2 [ Time Frame: Week 38, 46 and Week 54 (pre-dose) ]
    EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
15. Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3 [ Time Frame: Week 62, 70 and Week 78 ]
    EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
16. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 [ Time Frame: Baseline (Day 1) up to Week 30 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
17. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 [ Time Frame: Baseline (Week 30 pre-dose) up to Week 54 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
18. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 [ Time Frame: Baseline (Week 54 pre-dose) up to Week 78 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
19. Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1 [ Time Frame: Baseline (Day 1) up to Week 30 ]
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
20. Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2 [ Time Frame: Baseline (Week 30 pre-dose) up to Week 54 ]
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
21. Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3 [ Time Frame: Baseline (Week 54 pre-dose) up to Week 78 ]
    AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
22. Number of Participants With Laboratory Abnormalities: Period 1 [ Time Frame: Baseline (Day 1) up to Week 30 ]
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.
23. Number of Participants With Laboratory Abnormalities: Period 2 [ Time Frame: Baseline (Week 30 pre-dose) up to Week 54 ]
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.
24. Number of Participants With Laboratory Abnormalities: Period 3 [ Time Frame: Baseline (Week 54 pre-dose) up to Week 78 ]
    Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.
25. Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30 ]
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
26. Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2 [ Time Frame: Baseline (Week 30 pre-dose), Week 38, 46 and Week 54 ]
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
27. Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3 [ Time Frame: Baseline (Week 54 pre-dose), Week 62, 70 and 78 ]
    Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
28. 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 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30 ]
    PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
29. 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 [ Time Frame: Baseline (Week 30 pre-dose), Week 38, 46 and 54 ]
    PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
30. 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 [ Time Frame: Baseline (Week 54 pre-dose), Week 62, 70 and 78 ]
    PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
31. Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1 [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30 ]
32. Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2 [ Time Frame: Baseline (Week 30 pre-dose), Week 38, 46 and 54 ]
33. Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3 [ Time Frame: Baseline (Week 54 pre-dose), Week 62, 70 and 78 ]
34. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1 [ Time Frame: Baseline (Day 1) up to Week 30 ]
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
35. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2 [ Time Frame: Baseline (Week 30 pre-dose) up to Week 54 ]
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
36. Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3 [ Time Frame: Baseline (Week 54 pre-dose) up to Week 78 ]
    ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
37. Serum Concentration Versus Time Summary: Period 1 [ Time Frame: Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29 ]
38. Serum Concentration Versus Time Summary: Period 2 [ Time Frame: Pre dose on Day 211, 267, 379 and 547 ]
39. Serum Concentration Versus Time Summary: Period 3 [ Time Frame: Pre dose on Day 379, 435 and 547 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

Achieve Clinical Research, LLC

Birmingham, Alabama, United States, 35216

Clinical and Translational Research Center of Alabama, PC

Tuscaloosa, Alabama, United States, 35406

United States, Arizona

Sun Valley Arthritis Center, Ltd.

Peoria, Arizona, United States, 85381

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States, 85037

United States, California

St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

Fullerton, California, United States, 92835

Arthritis & Osteoporosis Medical Center

La Palma, California, United States, 90623

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States, 91786

Desert Valley Medical Group

Victorville, California, United States, 92395

United States, Delaware

Javed Rheumatology Associates, Inc

Newark, Delaware, United States, 19713

United States, Florida

Arthritis and Rheumatic Disease Specialties

Aventura, Florida, United States, 33180

International Medical Research

Daytona Beach, Florida, United States, 32117

Daytona Beach, Florida, United States, 32117

San Marcus Research Clinic, Inc.

Miami, Florida, United States, 33015

Advance Medical Research Services Corporation

Miami, Florida, United States, 33165

Sarasota Arthritis Research Center

Sarasota, Florida, United States, 34239

Alastair C. Kennedy, MD

Vero Beach, Florida, United States, 32960

Indian River Primary Care

Vero Beach, Florida, United States, 32960

United States, Georgia

Harbin Clinic

Rome, Georgia, United States, 30165

United States, Idaho

Advanced Clinical Research

Meridian, Idaho, United States, 83642

United States, Illinois

Methodist Medical Center of IL

Peoria, Illinois, United States, 61636

United States, Iowa

Physician's Clinic of Iowa, P.C.

Cedar Rapids, Iowa, United States, 52403

United States, Kentucky

Gilbert-Graves Clinic

Bowling Green, Kentucky, United States, 42101

Graves-Gilbert Clinic Bowling Green

Bowling Green, Kentucky, United States, 42101

United States, Louisiana

Ochsner Clinic Baton Rouge

Baton Rouge, Louisiana, United States, 70809

Arthritis and Diabetes Clinic, Inc.

Monroe, Louisiana, United States, 71203

United States, Maryland

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States, 20902

United States, Michigan

Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research

Battle Creek, Michigan, United States, 49015

United States, New Jersey

Arthritis, Rheumatic & Back Disease Associates

Voorhees, New Jersey, United States, 08043

United States, North Dakota

Trinity Health Center-Medical Arts

Minot, North Dakota, United States, 58701

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, United States, 19610

United States, South Carolina

Low Country Rheumatology, PA

Charleston, South Carolina, United States, 29406

United States, South Dakota

Regional Health Clinical Research

Rapid City, South Dakota, United States, 57701

Regional Medical Clinic

Rapid City, South Dakota, United States, 57701

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

Ramesh C Gupta, MD

Memphis, Tennessee, United States, 38119

United States, Texas

Austin Regional Clinic

Austin, Texas, United States, 78731

Metroplex Clinical Research Center

Dallas, Texas, United States, 75231

Accurate Clinical Research, Inc.

Houston, Texas, United States, 77034

Accurate Clinical Research

Nassau Bay, Texas, United States, 77058

United States, Virginia

Pharmacy Services, Sentara Leigh Hospital

Norfolk, Virginia, United States, 23502

Sentara Medical Group, Clinical Research

Norfolk, Virginia, United States, 23502

United States, Washington

The Seattle Arthritis Clinic

Seattle, Washington, United States, 98133

Australia, Queensland

Gold Coast Private Hospital Pty Ltd

Southport, Queensland, Australia, 4215

HPS Pharmacies

Southport, Queensland, Australia, 4215

Paradise Arthritis and Rheumatology Pty Ltd

Southport, Queensland, Australia, 4215

Australia, South Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia, 5011

Australia, Western Australia

CliniPath Pathology

Osborne Park, Western Australia, Australia, 6017

R.K. Will Pty Ltd

Victoria Park, Western Australia, Australia, 6100

Bosnia and Herzegovina

Clinical Center University of Sarajevo

Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000

General Hospital "Prim.dr.Abdulah Nakas"

Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000

University Clinical Center Tuzla

Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina, 75000

University Hospital Clinical Center Banja Luka

Banja Luka, Bosnia and Herzegovina, 78000

Brazil

CETI - Centro de Estudos em Terapias Inovadoras

Curitiba, Paraná, Brazil, 80030-110

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05652-900

Bulgaria

Multiprofile Hospital for Active Treatment Trimontium OOD

Plovdiv, Bulgaria, 4000

University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD

Plovdiv, Bulgaria, 4002

University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD

Sofia, Bulgaria, 1612

Canada, Ontario

Clinical Research and Arthritis Center

Windsor, Ontario, Canada, N8X 2C9

Czechia

CCBR Czech Brno, s.r.o.

Brno, Czechia, 602 00

Lekarna Lancier, s.r.o.

Brno, Czechia, 602 00

BENU Lekarna

Pardubice, Czechia, 530 02

CCBR-SYNARC a.s.

Pardubice, Czechia, 530 02

CCBR Czech Prague, s.r.o.

Praha 3, Czechia, 130 00

Lekarna U Robina, s.r.o.

Praha, Czechia, 130 00

Lekarna Hradebni s.r.o.

Uherske Hradiste, Czechia, 686 01

MEDICAL PLUS, s.r.o.

Uherske Hradiste, Czechia, 686 01

Georgia

LTD Tbilisi Central Hospital

Tbilisi, Georgia, 0159

LTD Unimedi Kakheti

Tbilisi, Georgia, 0159

Tbilisi Heart and Vascular Clinic LTD

Tbilisi, Georgia, 0159

LTD MediClubGeorgia

Tbilisi, Georgia, 0160

LTD Adapti

Tbilisi, Georgia, 0186

LTD Medulla" Chemotherapy and Immunotherapy Clinic

Tbilisi, Georgia, 0186

Germany

Schlosspark-Klinik

Berlin, Germany, 14059

Klinikum der Universität München

München, Germany, 80336

Elisabeth-Klinik gGmbH

Olsberg, Germany, 59939

Knappschaftsklinikum Saar GmbH

Puettlingen, Germany, 66346

Rheumazentrum Ratingen

Ratingen, Germany, 40878

Guatemala

Clínica Médica Especializada en Medicina Interna y Reumatología

Guatemala, Guatemala, 01010

Clínica Médica especializada en Medicina Interna

Guatemala, Guatemala, 01011

Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)

Guatemala, Guatemala, 01015

Therapeutic Research Institute and Lab S.A

Guatemala, Guatemala, 01015

Hungary

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, Hungary, 8230

Qualiclinic Kft.

Budapest, Hungary, 1036

Israel

Rambam Health Care Campus

Haifa, Israel, 3109601

Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

Jerusalem, Israel, 91120

Meir Medical Center

Kfar Saba, Israel, 4428164

Japan

Anjo Kosei Hospital

Anjo-shi, Aichi, Japan, 446-8602

Aso Iizuka Hospital

Iiduka, Fukuoka, Japan, 820-8505

Inoue Hospital

Takasaki, Gunma, Japan, 370-0053

Mazda Hospital

Aki-gun, Hiroshima, Japan, 735-8585

Sapporo City General Hospital

Sapporo, Hokkaido, Japan, 060-8604

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

Matsubara Mayflower Hospital

Katoh, Hyogo, Japan, 673-1462

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, Japan, 252-0392

Yokohama Minami Kyosai Hospital

Yokohama, Kanagawa, Japan, 236-0037

National Hospital Organization Nagasaki Medical Center

Omura, Nagasaki, Japan, 856-8562

Sasebo Chuo Hospital

Sasebo, Nagasaki, Japan, 857-1195

Kurashiki Sweet Hospital

Kurashiki, Okayama, Japan, 710-0016

Yuaikai Tomishiro Central Hospital

Tomigusuku, Okinawa, Japan, 901-0243

Saitama Medical Center

Kawagoe-shi, Saitama, Japan, 350-8550

Hirose Clinic

Tokorozawa-shi, Saitama, Japan, 359-1111

National Hospital Organization Shizuoka Medical Center

Sunto-gun, Shizuoka, Japan, 411-8611

St. Luke's International Hospital

Chuo-ku, Tokyo, Japan, 104-8560

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, Japan, 153-8515

Showa University Hospital

Shinagawa-ku, Tokyo, Japan, 142-8666

National Hospital Organization Chiba-East Hospital

Chiba, Japan, 260-8712

Kondo clinic for rheumatism and orthopaedics

Fukuoka, Japan, 810-0001

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan, 810-8563

Kumamoto Orthopaedic Hospital

Kumamoto, Japan, 862-0976

Jordan

Jordan Hospital

Amman, Jordan, 11152

King Abdullah University Hospital

Irbid, Jordan, 22110

Korea, Republic of

Chungnam National University Hospital

Daejeon, Korea, Republic of, 35015

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Hanyang University Seoul Hospital

Seoul, Korea, Republic of, 04763

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 120-752

Konkuk University Medical Center

Seoul, Korea, Republic of, 143-729

Lithuania

LSMUL Kauno klinikos

Kaunas, Lithuania, LT-50009

Mexico

Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

San Luis De Potosí, SAN LUIS DE Potosi, Mexico, 78213

Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"

Zona Universitaria, SAN LUIS DE Potosi, Mexico, CP 78240

Unidad Reumatologica Las Americas S.C.P

Merida, Yucatan, Mexico, CP 97000

Morocco

El Ayachi Hospital

Salé, Morocco, 11150

Groupe Radiologique de Salé

Salé, Morocco, 11150

Laboratoire les Arcades d'Analyses Médicales

Salé, Morocco, 11150

Peru

Hospital María Auxiliadora - Centro de Investigaciones Medicas

San juan de Miraflores, Lima, Peru, Lima 29

Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva

Santiago de Surco, Lima, Peru, Lima 33

Centro de diagnóstico por imágenes, Radiología General y Especial

Arequipa, Peru, CP656

Unidad de Investigación en Medicina Interna y Enfermedades Críticas

Arequipa, Peru, CP656

Centro de Investigación Reumatología CAA

Lima, Peru, Lima 27

Clinica Medica Cayetano Heredia

Lima, Peru, Lima 31

Servicio de Inmunología y Reumatología

Lima, Peru, Lima 31

Philippines

Mary Mediatrix Medical Center

Lipa City, Batangas, Philippines, 4217/043

Southern Philippines Medical Center

Davao, Davao DEL SUR, Philippines, 8000

Makati Medical Center

Makati, Metro Manila, Philippines, 1229

Medical Center Manila

Manila, Philippines, 1000

Philippine General Hospital

Manila, Philippines, 1000

St. Luke's Medical Center

Quezon, Philippines, 1102

Poland

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz, Poland, 85-168

Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji

Krakow, Poland, 31-121

NZOZ Lecznica MAK-MED. S.C.

Nadarzyn, Poland, 05-830

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sol, Poland, 67-100

MTZ Clinical Research Sp. z o.o.

Warszawa, Poland, 02-106

Romania

Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"

Galati, Romania, 800578

Spitalul Clinic de Recuperare Iasi

Iasi, Romania, 700656

Spitalul Clinic Judetean de Urgenta Targu Mures

Targu Mures, Romania, 540136

Russian Federation

GBUZ "Republican hospital n.a. V.A.Baranov"

Petrozavodsk, Republic OF Karelia, Russian Federation, 185019

GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"

Kemerovo, Russian Federation, 650000

KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"

Krasnoyarsk, Russian Federation, 660014

Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky

Krasnoyarsk, Russian Federation, 660022

GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region

Kursk, Russian Federation, 305007

GBUZ of city of Moscow

Moscow, Russian Federation, 129327

GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"

Ryazan, Russian Federation, 390026

GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"

Ryazan, Russian Federation, 390026

GBU of Ryazan region "Regional clinical cardiology dispanser"

Ryazan, Russian Federation, 390026

GBOU of Ryazan region "Regional clinical hospital"

Ryazan, Russian Federation, 390039

Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis

Saint-Petersburg, Russian Federation, 190068

GUZ "Regional clinical hospital"

Saratov, Russian Federation, 410053

GBUZ VO 'Regional clinical hospital"

Vladimir, Russian Federation, 600023

GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"

Yaroslavl, Russian Federation, 150002

Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia, 11 000

Military Medical Academy

Belgrade, Serbia, 11 000

Institute for Treatment and Rehabilitation "Niska Banja"

Niska Banja, Serbia, 18205

South Africa

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa, 2193

Jakaranda Hospital

Pretoria, Gauteng, South Africa, 0002

Emmed Research

Pretoria, Gauteng, South Africa, 0084

Arthritis Clinical Research Unit

Cape Town, Western CAPE, South Africa, 7405

Vincent Pallotti Hospital

Cape Town, Western CAPE, South Africa, 7405

Tunisia

Mohamed Kassab Institute of orthopedics

Manouba, Tunisia, 2010

Rabta Hospital

Tunis, Tunisia, 1007

Ukraine

Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut

Dnipropetrovsk, Ukraine, 49027

Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad

Ivano-Frankivsk, Ukraine, 76008

Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"

Kharkiv, Ukraine, 61176

Khmelnytska oblasna likarnia

Khmelnytskyi, Ukraine, 29000

Kyivska miska klinichna likarnia #6

Kyiv, Ukraine, 03680

Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy

Lviv, Ukraine, 79014

Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"

M. Kryvyi Rih, Ukraine, 50056

Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"

M. Sumy, Ukraine, 40022

Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne

M. Vinnytsia, Ukraine, 21018

Komunalna ustanova "Odeska oblasna klinichna likarnia"

Odesa, Ukraine, 65025

Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)

Odesa, Ukraine, 65026

Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady

Zaporizhzhia, Ukraine, 69600

United Kingdom

Wrightington Hospital

Wigan, Lancashire, United Kingdom, WN6 9EP

Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust

Maidstone, United Kingdom, ME16 9QQ

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423.

Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. 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. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z.

Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.

Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. 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. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019.

Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. 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. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02222493
• Other Study ID Numbers: B5371002; REFLECTIONS B537-02 ( Other Identifier: Alias ID ); 2013-004148-49 ( EudraCT Number )
• First Posted: August 21, 2014
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018
• Last Verified: April 2018

Keywords provided by Pfizer:

Phase 3; infliximab; rheumatoid arthritis

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infliximab; Dermatologic Agents; Gastrointestinal Agents; Antirheumatic Agents