Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 1177 for:    MYCOPHENOLIC ACID

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

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: NCT00594932
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : December 27, 2012
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Joan Merrill, MD, Oklahoma Medical Research Foundation

Tracking Information
First Submitted Date  ICMJE January 4, 2008
First Posted Date  ICMJE January 16, 2008
Last Update Posted Date December 27, 2012
Study Start Date  ICMJE November 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
Complete response (</= 0.25 tender and swollen joints at baseline and BILAG C or D score in Musculoskeletal system) at three months, comparing treatment to placebo group [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00594932 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2008)
  • Adverse events assessed by organ system comparing treatment vs placebo [ Time Frame: 3 months and 6 months ]
  • Changes in inflammatory markers (surface expression of cell activation markers and circulating cytokines) in response to Cellcept vs placebo [ Time Frame: 3 months and 6 months ]
  • Special Ancillary study: Effects of treatment vs placebo on activation of circulating endothelial cells and nitric oxide (in collaboration with Dr. Robert Clancy of New York University Medical Center) [ Time Frame: 3 months and 6 months ]
  • Expression of interferon alpha inducible gene panel and inosine-monophosphate dehydrogenase II expression in response to mycophenolate vs placebo [ Time Frame: 3 months and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Official Title  ICMJE Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Brief Summary We hypothesize that mycophenolate mofetil(Cellcept)is safe and effective for lupus arthritis. In this study, patients with lupus will be randomly assigned to receive mycophenolate mofetil or placebo (inert pills) for three months. At the end of three months all patients will receive mycophenolate mofetil for three additional months. The effectiveness on arthritis and other symptoms of lupus will be measured by joint counts and by the BILAG instrument (a measure of overall lupus disease activity. Additionally special blood tests aimed at understanding the biologic effects of mycophenolate mofetil will also be performed at some visits. The primary outcome measurement will be the safety and effectiveness of this treatment (as compared to placebo) at the three month point. The trial will continue in a blinded fashion (neither the investigator or the participants know who is getting mycophenolate and who is getting placebo) until 24 patients have completed the first three months of the protocol.
Detailed Description

Patients and Methods:

27 patients with active BILAG B or A arthritis, with at least 6 swollen and 6 tender joints entered a six month study of MMF vs placebo for three months followed by open label MMF. 14 patients (12 women and 2 men) received placebo at baseline and 13 patients (11 women and 2 men) received MMF. Primary Outcome was Major Clinical Response at 3 months, then all patients received open label Cellcept for another 3 months. Blood was drawn for safety, lupus disease activity measures and exploratory Biomarkers, Joint counts were performed monthly. At baseline background DMARDs were stopped. Plaquenil was allowed. All patients received 160 mg depomedrol at baseline and were allowed 80 mg shots at subsequent months after blood draws and procedures had been completed.

Baseline Characteristics:

At entry into the study, there was no difference between MMF and placebo in: age, gender, ethnicity, number of ACR criteria for lupus, or number of swollen and tender joints.

DEFINITION of RESPONSE

Prespecified Primary Endpoint: Complete Clinical Response:

BILAG C in musculoskeletal by Week 12 and decrease to 0.25 or less of tender +swollen jt counts

Prespecified Secondary Endpoint: Partial response:

One letter drop in musculoskeletal by Week 12 OR decrease to 0.5 or less tender + swollen jt counts

Exploratory Measure (not prespecified): Major Clinical Response:

BILAG C in musculoskeletal by Week 12 and decrease to 0.5 or less of tender +swollen jt counts. (In the primary analysis the one patient who met this endpoint was designated as a partial responder since those prespecified criteria were also met.

Non response:

Does not meet above criteria for complete or partial response

Additional Measures: (prespecified secondary endpoints) included joint counts, changes in BILAG and SLEDAI and physician and patient global assessments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Arthritis
Intervention  ICMJE
  • Drug: mycophenolate mofetil
    First treatment month: mycophenolate mofetil ascending doses orally Second treatment month to end of study: mycophenolate mofetil 3 gms/day (or less if tolerance issues arise)
    Other Names:
    • mycophenolate
    • Cellcept
  • Other: placebo
    oral placebo will be given in ascending "doses" during the first month and at full "dose" during the second and third month (or at lower "dose" if tolerance issues warrant)
    Other Names:
    • inert tablet
    • oral placebo pill
  • Drug: Mycophenolate mofetil
    Please see the Arm Description
    Other Name: Cellcept
Study Arms  ICMJE
  • Experimental: Arm I:
    Participants randomly assigned to Arm I will receive mycophenolate mofetil in ascending doses during Month 1, and 3 grams/day (or less if there are tolerance issues) for Months 2 through 6.
    Intervention: Drug: mycophenolate mofetil
  • Placebo Comparator: Arm 2a
    Patients Randomly Assigned to Arm 2 will enter Arm 2a for three months as a placebo comparator. The placebo treatment will be structured so that they will undergo the same type of dosing in Month 1 that the ascending dose patient from Arm 1 undergo, but will have placebo in both bottles of pills. At the end of three months, after assessment of primary outcome, these patients enter Arm 2b which is a treatment arm.
    Intervention: Other: placebo
  • Active Comparator: Arm 2b Open Lable Mycophenolate Mofetil
    Arm 2b begins for patients in Arm 2 after three months. They will receive ascending doses of mycophenolate for the first month (which is Month 4 of the study). This will still be blinded since patients in Arm 1 will be undergoing an identical ascending dose regimen during this month, except that there will be active treatment in both bottles. At the end of Month 4 all patients will know that they are on full dose of 3 gms/day mycophenolate (or a lower dose if there are tolerance issues).
    Intervention: Drug: Mycophenolate mofetil
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: January 11, 2012)
27
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2008)
24
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of SLE by the 1995 modification of revised ACR criteria (includes antiphospholipid antibodies)
  2. BILAG A arthritis or BILAG B arthritis with at least 6 tender and 4 swollen joints at screening and baseline
  3. Stable prednisone dose at 20 mg of less for one month at baseline.
  4. If on antimalarials must be stable for at least one month at baseline
  5. If on NSAIDS must be on a stable regimen for at least one month but can be prn dosing
  6. Must be willing to withdraw from azathioprine or MTX at the time of screening.
  7. Between ages 14 and 70
  8. Women of childbearing potential must have a negative pregnancy test at screening and at each month during the study.
  9. All participants (male and female) must, if fertile, agree to practice contraception during the entire course of the study. This may include barrier, oral contraceptives, depo-provera, intrauterine device and/or abstinence.

    -

Exclusion Criteria:

  1. Inability to understand informed consent
  2. Drug or alcohol abuse within the past six months
  3. In the opinion of the investigator, it is not likely the patient can comply with the protocol for any reason, or participation in the protocol is not in the patient's best interest.
  4. Unstable medical condition that, in the opinion of the investigator would contraindicate study participation
  5. History of malignancy (except for basal cell carcinoma at any time and/or cervical cancer or squamous cell cancer at least five years previous to screening).
  6. Use of cyclosporine, leflunomide, cyclophosphamide or ay biologic agent within three months prior to screening.
  7. Participation in any clinical study of an investigational agent within three months of screening -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 70 Years   (Child, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594932
Other Study ID Numbers  ICMJE OMRF 06-23
Aspreva Pharmaceuticals grant ( Other Grant/Funding Number: Aspreva Pharmaceutical Investigator-Initiated Study )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joan Merrill, MD, Oklahoma Medical Research Foundation
Study Sponsor  ICMJE Oklahoma Medical Research Foundation
Collaborators  ICMJE NYU Langone Health
Investigators  ICMJE
Principal Investigator: Joan T. Merrill, M.D. Oklahoma Medical Research Foundation
Study Chair: Robert Clancy, PhD NYU Langone Health
PRS Account Oklahoma Medical Research Foundation
Verification Date December 2012

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