Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02969044
Previous Study | Return to List | Next Study

Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02969044
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE November 21, 2016
Results First Submitted Date  ICMJE November 6, 2018
Results First Posted Date  ICMJE December 4, 2018
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE December 20, 2016
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 [ Time Frame: Baseline, Week 8 ]
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
Change from baseline in Simple Disease Activity Index (SDAI) [ Time Frame: Baseline, Week 8 ]
Change History Complete list of historical versions of study NCT02969044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Number of Participants With Vital Signs Abnormalities [ Time Frame: Baseline up to Week 12 ]
    Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.
  • Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to Week 12 ]
    Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.
  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 12 ]
    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 are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.
  • Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 [ Time Frame: Baseline, Week 1, 2, 4 and 6 ]
    The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Remission Rate Based on Simple Disease Activity Index Score [ Time Frame: Week 4, 6 and 8 ]
    Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) [ Time Frame: Week 4, 6 and 8 ]
    Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
  • Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) [ Time Frame: Week 4, 6 and 8 ]
    Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
  • Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) [ Time Frame: Week 4, 6 and 8 ]
    Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
  • Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) [ Time Frame: Week 4, 6 and 8 ]
    Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. 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.
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    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.
  • Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
  • Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    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.
  • Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    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.
  • Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 [ Time Frame: Baseline, Week 1, 2, 4, 6 and 8 ]
    HAQ-DI assess degree of difficulty a participant experienced (during 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: average of the 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2016)
  • Change from baseline in SDAI [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in SDAI low disease activity (LDAS) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in SDAI low disease activity (LDAS) remission rates [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in Disease Activity Score for 28 joints (DAS28) LDAS [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in DAS28 LDAS remission rates [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) DAS28-3 (ESR) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 variables) DAS28-3 (CRP) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) DAS28-4 (ESR) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) DAS28-4 (CRP) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in the Tender/Painful and Swollen Joint Count (28) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in the the Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in the the 8. Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in High Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in SDAI [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in SDAI [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in SDAI [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in SDAI low disease activity (LDAS) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in SDAI low disease activity (LDAS) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in SDAI low disease activity (LDAS) remission rates [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in SDAI low disease activity (LDAS) remission rates [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28 LDAS [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28 LDAS [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28 LDAS remission rates [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28 LDAS remission rates [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28-3 (ESR) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28-3 (ESR) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28-3 (ESR) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in DAS28-3 (ESR) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in DAS28-3 (CRP) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28-3 (CRP) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28-3 (CRP) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in DAS28-3 (CRP) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in DAS28-4 (ESR) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28-4 (ESR) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28-4 (ESR) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in DAS28-4 (ESR) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in DAS28-4 (CRP) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in DAS28-4 (CRP) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in DAS28-4 (CRP) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in DAS28-4 (CRP) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in the Patient Global Assessment of Arthritis (VAS) [ Time Frame: Baseline, Week 8 ]
  • Change from baseline in the Patient Global Assessment of Arthritis (VAS) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in the Patient Global Assessment of Arthritis (VAS) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in the Patient Global Assessment of Arthritis (VAS) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in the Patient Global Assessment of Arthritis (VAS) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in the Patient's Assessment of Arthritis Pain (VAS) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in the Tender/Painful and Swollen Joint Count (28) [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in the Tender/Painful and Swollen Joint Count (28) [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in the Tender/Painful and Swollen Joint Count (28) [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in the Tender/Painful and Swollen Joint Count (28) [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in the the Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in the the Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in the the Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in the the Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in the the HAQ-DI [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in the the HAQ-DI [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in the the HAQ-DI [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in the the HAQ-DI [ Time Frame: Baseline, Week 1 ]
  • Change from baseline in hsCRP [ Time Frame: Baseline, Week 6 ]
  • Change from baseline in hsCRP [ Time Frame: Baseline, Week 4 ]
  • Change from baseline in hsCRP [ Time Frame: Baseline, Week 2 ]
  • Change from baseline in hsCRP [ Time Frame: Baseline, Week 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Official Title  ICMJE A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Brief Summary This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Placebo
  • Drug: PF-06651600
    200mg pill every day (QD) for 8 weeks
Study Arms  ICMJE
  • Experimental: PF-06651600
    Study Drug
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
60
Actual Study Completion Date  ICMJE December 12, 2017
Actual Primary Completion Date December 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Subjects between the ages of 18 and 75 years, inclusive
  • Must have moderate-to-severe, active Rheumatoid Arthritis
  • Must have had an inadequate response to Methotrexate
  • Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

  • Subjects with any acute or chronic infections or infection history
  • Have acute or active chronic dermatological disorders prior to study start
  • Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
  • Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
  • Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Georgia,   Germany,   Hungary,   Poland,   Serbia,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02969044
Other Study ID Numbers  ICMJE B7981006
2016-002862-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP