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Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03781375
Recruitment Status : Terminated
First Posted : December 19, 2018
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Juvenile Rheumatoid Arthritis
Interventions Drug: Etanercept
Drug: Placebo to Etanerceot
Drug: Methotrexate
Enrollment 25
Recruitment Details This study was conducted at 7 centers in the United States. The study consisted of a 6-month double-blind treatment period followed by a 6-month open-label period where all participants received etanercept + methotrexate. Early transition to open-label treatment was allowed after 2 months of blinded treatment, for disease flare or lack of response.
Pre-assignment Details Participants were randomized equally into 1 of 2 treatments for the double-blind portion of the study. Randomization was stratified by route of methotrexate administration (oral [PO] vs subcutaneous [SC]) prior to randomization.
Arm/Group Title Methotrexate + Placebo Methotrexate + Etanercept
Hide Arm/Group Description Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Period Title: Double-blind Phase
Started 12 13
Received Study Drug 12 13
Completed 5 7
Not Completed 7 6
Reason Not Completed
Adverse Event             0             1
Lack of Response             6             2
Other             1             3
Period Title: Open-label Phase
Started [1] 11 9
Received Study Drug 10 9
Completed 8 6
Not Completed 3 3
Reason Not Completed
Protocol Issues             0             1
Suboptimal Clinical Response             1             0
Other             2             2
[1]
Participants who completed blinded treatment or who withdrew early due to flare or lack of response
Arm/Group Title Methotrexate + Placebo Methotrexate + Etanercept Total
Hide Arm/Group Description Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months. Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
8.75  (5.71) 11.38  (3.40) 10.12  (4.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
7
  58.3%
6
  46.2%
13
  52.0%
Male
5
  41.7%
7
  53.8%
12
  48.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
White
10
  83.3%
10
  76.9%
20
  80.0%
Black
2
  16.7%
0
   0.0%
2
   8.0%
Hispanic
0
   0.0%
2
  15.4%
2
   8.0%
Oher
0
   0.0%
1
   7.7%
1
   4.0%
Methotrexate Dosage Route   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Orally
5
  41.7%
6
  46.2%
11
  44.0%
Subcutaneously
7
  58.3%
7
  53.8%
14
  56.0%
[1]
Measure Description: Randomization was stratified on methotrexate dose route.
Type of Arthritis at Onset  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Pauciarticular
1
   8.3%
4
  30.8%
5
  20.0%
Polyarticular
7
  58.3%
9
  69.2%
16
  64.0%
Systemic
4
  33.3%
0
   0.0%
4
  16.0%
1.Primary Outcome
Title Percentage of Participants With a JRA Response at Month 6
Hide Description

Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 30% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

  • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
  • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
  • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
  • Number of joints with limitation of motion
  • Childhood Health Assessment Questionnaire (CHAQ)
  • Erythrocyte sedimentation rate (ESR)
Time Frame Baseline and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; participants with missing data are counted as non-responders.
Arm/Group Title Methotrexate + Placebo Methotrexate + Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of participants
33 38
2.Secondary Outcome
Title Percentage of Participants With a 50% Improvement in JRA DOI at Month 6
Hide Description

Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 50% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

  • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
  • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
  • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
  • Number of joints with limitation of motion
  • Childhood Health Assessment Questionnaire (CHAQ)
  • Erythrocyte sedimentation rate (ESR)
Time Frame Baseline and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; participants with missing data were counted as non-responders.
Arm/Group Title Methotrexate + Placebo Methotrexate + Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of participants
25 38
3.Secondary Outcome
Title Percentage of Participants With a 70% Improvement in JRA DOI at Month 6
Hide Description

Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 70% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

  • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
  • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
  • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
  • Number of joints with limitation of motion
  • Childhood Health Assessment Questionnaire (CHAQ)
  • Erythrocyte sedimentation rate (ESR)
Time Frame Baseline and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants; participants with missing data were counted as non-responders.
Arm/Group Title Methotrexate + Placebo Methotrexate + Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of participants
8 38
Time Frame Up to 12 months on-study evaluations plus 1 month follow-up
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Methotrexate + Placebo (Blinded Phase) Methotrexate + Etanercept (Blinded Phase) Methotrexate + Etanercept (Open Label Phase)
Hide Arm/Group Description Participants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. Participants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
All-Cause Mortality
Methotrexate + Placebo (Blinded Phase) Methotrexate + Etanercept (Blinded Phase) Methotrexate + Etanercept (Open Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methotrexate + Placebo (Blinded Phase) Methotrexate + Etanercept (Blinded Phase) Methotrexate + Etanercept (Open Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   1/13 (7.69%)   0/19 (0.00%) 
Infections and infestations       
Appendicitis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methotrexate + Placebo (Blinded Phase) Methotrexate + Etanercept (Blinded Phase) Methotrexate + Etanercept (Open Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   12/13 (92.31%)   15/19 (78.95%) 
Blood and lymphatic system disorders       
Anaemia  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Leukopenia  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Lymphadenopathy  1  0/12 (0.00%)  2/13 (15.38%)  1/19 (5.26%) 
Ear and labyrinth disorders       
Cerumen impaction  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Ear pain  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Tinnitus  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Eye disorders       
Blepharospasm  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Uveitis  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Vision blurred  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  2/12 (16.67%)  3/13 (23.08%)  2/19 (10.53%) 
Abdominal pain upper  1  2/12 (16.67%)  1/13 (7.69%)  2/19 (10.53%) 
Abdominal tenderness  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Constipation  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Diarrhoea  1  3/12 (25.00%)  0/13 (0.00%)  3/19 (15.79%) 
Flatulence  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Gastritis  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Mouth ulceration  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Nausea  1  1/12 (8.33%)  1/13 (7.69%)  0/19 (0.00%) 
Rectal haemorrhage  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Stomatitis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Vomiting  1  3/12 (25.00%)  3/13 (23.08%)  3/19 (15.79%) 
General disorders       
Chest pain  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Fatigue  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Injection site erythema  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Injection site pain  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Injection site pruritus  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Injection site rash  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Injection site reaction  1  0/12 (0.00%)  0/13 (0.00%)  3/19 (15.79%) 
Oedema peripheral  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Pain  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Peripheral swelling  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Pyrexia  1  2/12 (16.67%)  0/13 (0.00%)  0/19 (0.00%) 
Immune system disorders       
Seasonal allergy  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Infections and infestations       
Beta haemolytic streptococcal infection  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Cellulitis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Chronic sinusitis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Fungal skin infection  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Gastroenteritis  1  0/12 (0.00%)  0/13 (0.00%)  2/19 (10.53%) 
Gastroenteritis viral  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Influenza  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Otitis media  1  2/12 (16.67%)  0/13 (0.00%)  3/19 (15.79%) 
Pharyngitis  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Rhinitis  1  0/12 (0.00%)  0/13 (0.00%)  2/19 (10.53%) 
Sinusitis  1  2/12 (16.67%)  1/13 (7.69%)  2/19 (10.53%) 
Upper respiratory tract infection  1  2/12 (16.67%)  4/13 (30.77%)  2/19 (10.53%) 
Urinary tract infection  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Meniscus injury  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Mouth injury  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Thermal burn  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Investigations       
Blood pressure diastolic increased  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Body temperature increased  1  1/12 (8.33%)  0/13 (0.00%)  1/19 (5.26%) 
Liver function test increased  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Lymph node palpable  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Dehydration  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Arthritis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Back pain  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Flank pain  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Muscle spasms  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Muscular weakness  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Musculoskeletal pain  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Pain in extremity  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Rheumatoid arthritis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Nervous system disorders       
Dizziness  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Headache  1  3/12 (25.00%)  6/13 (46.15%)  3/19 (15.79%) 
Hypoaesthesia  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Lethargy  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Migraine  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Tongue biting  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Psychiatric disorders       
Aggression  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Depression  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Tic  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Renal and urinary disorders       
Haematuria  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Nephrolithiasis  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Proteinuria  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/12 (8.33%)  2/13 (15.38%)  0/19 (0.00%) 
Epistaxis  1  1/12 (8.33%)  1/13 (7.69%)  0/19 (0.00%) 
Nasal congestion  1  0/12 (0.00%)  1/13 (7.69%)  1/19 (5.26%) 
Oropharyngeal pain  1  0/12 (0.00%)  3/13 (23.08%)  3/19 (15.79%) 
Respiratory disorder  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Rhinitis allergic  1  1/12 (8.33%)  2/13 (15.38%)  0/19 (0.00%) 
Rhinorrhoea  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Sinus congestion  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Upper respiratory tract congestion  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Upper-airway cough syndrome  1  0/12 (0.00%)  2/13 (15.38%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Ecchymosis  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Eczema  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Pruritus  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Pseudoporphyria  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Rash  1  0/12 (0.00%)  3/13 (23.08%)  4/19 (21.05%) 
Rash erythematous  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Rash pruritic  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Skin atrophy  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Skin burning sensation  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Skin discolouration  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Skin exfoliation  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Skin fissures  1  0/12 (0.00%)  0/13 (0.00%)  1/19 (5.26%) 
Skin hypopigmentation  1  1/12 (8.33%)  0/13 (0.00%)  0/19 (0.00%) 
Vascular disorders       
Hot flush  1  0/12 (0.00%)  1/13 (7.69%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03781375     History of Changes
Other Study ID Numbers: 20021628
016.0028 ( Other Identifier: Immunex Corporation )
First Submitted: December 18, 2018
First Posted: December 19, 2018
Results First Submitted: June 12, 2019
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019