Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis
NCT ID: NCT01261403
Last Updated: 2020-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2010-12-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
1 Unit of PDA001 or 4 units Vehicle Control intravenous on Day 0 and Day 7
PDA001
Dose escalation study: Subjects will be assigned to 1 of 2 treatment groups (1 unit or 4 units vs. vehicle control) based on the order in which they enroll in the study. Intravenous infusion will be administered on days 0 and 7. Nonresponders will be unblinded after 12 weeks of study. Non- responders on vehicle control will be re-dosed with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart). Nonresponders taking active PDA001 will enter the safety follow-up portion of the study. Responders at 12 weeks will continue in the safety and efficacy follow-up portion of the study until 12 months of study. Responders will be treated for RA flare between 3-9 months of study with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart).
Vehicle Controlled Placebo
Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7
Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7
Group 2
4 Units PDA001 or 4 units Vehicle Control intravenous (Placebo) on Day 0 and Day 7
PDA001
Dose escalation study: Subjects will be assigned to 1 of 2 treatment groups (1 unit or 4 units vs. vehicle control) based on the order in which they enroll in the study. Intravenous infusion will be administered on days 0 and 7. Nonresponders will be unblinded after 12 weeks of study. Non- responders on vehicle control will be re-dosed with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart). Nonresponders taking active PDA001 will enter the safety follow-up portion of the study. Responders at 12 weeks will continue in the safety and efficacy follow-up portion of the study until 12 months of study. Responders will be treated for RA flare between 3-9 months of study with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart).
Vehicle Controlled Placebo
Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7
Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7
Vehicle control
Placebo - Vehicle Control Arm
Vehicle Controlled Placebo
Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7
Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7
Interventions
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PDA001
Dose escalation study: Subjects will be assigned to 1 of 2 treatment groups (1 unit or 4 units vs. vehicle control) based on the order in which they enroll in the study. Intravenous infusion will be administered on days 0 and 7. Nonresponders will be unblinded after 12 weeks of study. Non- responders on vehicle control will be re-dosed with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart). Nonresponders taking active PDA001 will enter the safety follow-up portion of the study. Responders at 12 weeks will continue in the safety and efficacy follow-up portion of the study until 12 months of study. Responders will be treated for RA flare between 3-9 months of study with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart).
Vehicle Controlled Placebo
Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7
Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7
Eligibility Criteria
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Inclusion Criteria
1. Diagnosis of RA as defined by the 1987-revised ACR criteria.
2. RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints at Screening and Baseline, and at least 2 of the following: a C reactive protein level (CRP), greater than the upper limit of normal (ULN) ³ 1 mg/dl, an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour, or morning stiffness lasting longer than 45 minutes.
3. Non responsive or intolerant to a minimum of 2 RA therapies which are classified as DMARDs, biologics, or corticosteroids.
4. Biological medication must be discontinued 30 day prior to the first dose of study drug, except golimumab and actemra which are 60 days, and infliximab, alefacept and efalizumab, which must have been discontinued 90 days prior to the first dose of IP.
5. Cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents must have been discontinued 90 days prior to the first dose of IP.
6. Subjects must be able to tolerate intravenous infusions in both arms.
7. There should be no change in RA medication dose anticipated during the initial treatment and re treatment periods and the respective 12 week follow-up period for each dosing treatment period. The following rules apply for anti-rheumatic medications taken during the study:
8. DMARDs must have must have been stable for least 90 days prior to dosing with IP.
9. Low -dose corticosteroids are permitted (prednisolone ≤ 10 mg per day or equivalent). Corticosteroids must have been stable for at least 30 days prior to dosing with IP.
10. DMARDs and corticosteroids must remain stable throughout the initial 3 months of study and throughout subsequent treatment periods
The presence of any of the following will exclude a subject from enrollment:
1. Prior use of rituximab and other B-cell depleting therapies, abatacept, prior use of more than 2 biologic therapies.
2. Subject has received an investigational agent in any indication-within 60 days (or 5 half-lives, whichever is longer) prior to treatment with IP.
3. Subject has received previous cell therapy.
4. Serum creatinine concentration \> 2.0 mg/dl at screening.
5. Alkaline phosphatase \> 2.5x the upper limit of normal at screening.
6. Bilirubin level \> 1.5 mg/dL (unless subject has known Gilbert's disease).
7. Untreated chronic infection or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP.
8. Positive HIV test at Screening. Positive Hepatitis B surface antigen at Screening. Positive Hepatitis C antibody at Screening.
9. Organic heart disease (e.g., congestive heart failure), myocardial infarction within six (6) months prior to screening or clinically significant findings on ECG at screening. Clinically significant arrhythmia.
10. Primary or secondary immunodeficiency.
18 Years
75 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Celularity Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Solveig Ericson, MD
Role: STUDY_DIRECTOR
Celularity Incorporated
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Advanced Pain Research Institute
Arcadia, California, United States
UCLA
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
Sanitas Research
Coral Gables, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Four Rivers Clinical Research Inc.
Paducah, Kentucky, United States
Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, United States
SNS Rheumatology
Lakewood, New Jersey, United States
David R. Mandel, MD, Inc.
Mayfield, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Countries
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Other Identifiers
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CCT-PDA001-RA-001
Identifier Type: -
Identifier Source: org_study_id
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