Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Cellular Therapeutics
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01261403
First received: December 15, 2010
Last updated: September 5, 2013
Last verified: September 2013

December 15, 2010
September 5, 2013
December 2010
February 2012   (final data collection date for primary outcome measure)
ACR 20 response after 12 weeks of study [ Time Frame: Week 12 (3 months) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261403 on ClinicalTrials.gov Archive Site
ACR20/50/70, ACR hybrid, Clinical Disease Activity Index , Das 28 and EULAR response, rheumatoid factor, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6 [ Time Frame: Maximum duration of the safety and efficacy period is 12 Months. ] [ Designated as safety issue: No ]
ACR20/50/70, ACR hybrid, Cinical Disease Activity Index , Das 28 and EULAR response, rheumatoid factor, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6 [ Time Frame: Maximum duration of the safety and efficacy period is 12 Months. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis
A Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid Arthritis

The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare of RA symptoms and to quantify changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: 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).
  • Other: Vehicle Controlled Placebo
  • Experimental: Group 1
    1 Unit of PDA001 versus Vehicle Control
    Interventions:
    • Biological: PDA001
    • Other: Vehicle Controlled Placebo
  • Experimental: Group 2
    4 Units PDA001 versus Vehicle Control
    Interventions:
    • Biological: PDA001
    • Other: Vehicle Controlled Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
26
September 2013
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261403
CCT-PDA001-RA-001
Yes
Celgene Corporation
Celgene Corporation
Celgene Cellular Therapeutics
Study Director: Steven Fischkoff, MD Celgene Cellular Therapeutics, a division of Celgene Corporation
Celgene Corporation
September 2013

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