Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094380
Other study ID # DAIT ITN002AI
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 16, 2004
Last updated January 10, 2017
Start date September 2004
Est. completion date January 2006

Study information

Verified date January 2017
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety of a single dose of RG2077 in patients with systemic lupus erythematosus (SLE) who are currently receiving cyclophosphamide. This study will also determine if RG2077 is effective in decreasing disease activity in these patients.

Study hypothesis: CTLA4-Ig mediates a T cell costimulatory blockade that effectively induces an antigen-specific nonresponsiveness in T cells.


Description:

SLE is a chronic, inflammatory autoimmune disorder that may affect many organ systems, including the skin, joints, and internal organs. RG2077 has been studied for use in multiple sclerosis, another autoimmune disorder. This study will evaluate the safety and efficacy of RG2077 in SLE patients who are currently receiving cyclophosphamide.

This trial is composed of two parts. The first part is a dose-escalation study in which participants will receive one of two doses of RG2077 (0.2 mg/kg or 2 mg/kg); this part of the study will last 60 days. At screening, patients will have an IV catheter inserted into their arms for administration of cyclophosphamide and RG2077. Patients will also have medical and medication history assessments, a comprehensive physical exam, and blood and urine tests. There are 5 study visits for the first part of the trial; these will occur at screening, at study entry, and Days 1, 14, and 28. Selected visits will include physical exam, vital signs measurement, blood and urine tests, and disease activity assessment. At Days 7 and 60, patients will be contacted by phone to report their medication history and any adverse effects they have experienced.

The second part of the study will evaluate a single 10 mg/kg dose of RG2077; this part of the study will last 90 days. In the study, participants will be randomly assigned to one of two groups. At the start of the study, Group 1 participants will receive RG2077 and cyclophosphamide and Group 2 participants will receive cyclophosphamide only. There will be 9 study visits; these will occur at study screening, study entry, and Days 1, 4, 7, 14, 28, and 60. At selected visits, patients will undergo physical exam, vital signs measurement, blood tests and urine tests, and disease activity assessment.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of SLE by American College of Rheumatology (ACR) criteria

- Concurrent treatment with intravenous cyclophosphamide (500 to 1000 mg/m2) for at least one of the following manifestations of lupus: World Health Organization (WHO) class III, IV, or V lupus nephritis; British Isles Lupus Assessment Group (BILAG) score of A for vasculitis; BILAG score of A for cytopenia; BILAG score of A for nervous system

- Stable medication regimen for at least 4 weeks prior to study entry

- Weight between 40 kg (88.2 lbs) and 125 kg (275.6 lb)

- Willing to use acceptable forms of contraception

Exclusion Criteria:

- Moderately severe anemia (hemoglobin less than 8 mg/dL)

- Neutropenia (absolute neutrophil count less than 1,500/mm3)

- Thrombocytopenia (platelets less than 50,000/mm3)

- Positive tuberculin (PPD) test without evidence of prior treatment or administration of bacille Calmette-Guérin (BCG) vaccine

- Active infections, including HIV and hepatitis B or C

- Receipt of a live vaccine within 3 months of study entry

- End-stage renal disease with creatinine clearance less than 20 ml/min/1.73 m2

- History of cancer. Patients with a history of carcinoma in situ and treated basal and squamous cell carcinomas are not excluded.

- Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CTLA4-IgG4m (RG2077)

Cyclophosphamide


Locations

Country Name City State
United States Columbia University Medical Center New York New York
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Davidson A, Diamond B, Wofsy D, Daikh D. Block and tackle: CTLA4Ig takes on lupus. Lupus. 2005;14(3):197-203. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety, as measured by the occurrence of adverse events Throughout study Yes
Secondary Renal function Throughout study Yes
Secondary Lupus serology Throughout study Yes
Secondary SLE disease activity Throughout study Yes
See also
  Status Clinical Trial Phase
Recruiting NCT02936375 - The Iguratimod Effect on Lupus Nephritis (IGeLU) Phase 2
Completed NCT03597464 - Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin Phase 3
Recruiting NCT01226147 - Efficacy and Safety of Tamibarotene(AM80) for Lupus Nephritis Phase 2
Completed NCT01206569 - Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis Phase 4
Active, not recruiting NCT00569101 - A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis Phase 2
Terminated NCT00368264 - TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL ) Phase 2/Phase 3
Completed NCT00298506 - Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V) N/A
Completed NCT00371319 - Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis Phase 4
Terminated NCT04376827 - A Study of Guselkumab in Participants With Active Lupus Nephritis Phase 2
Completed NCT03610516 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis. Phase 2
Recruiting NCT03526042 - Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis N/A
Withdrawn NCT03859570 - Pentoxifylline in Lupus Nephritis Phase 4
Completed NCT03664908 - Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN)? N/A
Completed NCT01085097 - A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis Phase 2
Active, not recruiting NCT05704088 - SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients Phase 4
Not yet recruiting NCT06429800 - A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Lupus Nephritis Phase 1
Recruiting NCT02226341 - ACTHar in the Treatment of Lupus Nephritis Phase 4
Recruiting NCT02453997 - Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis N/A
Completed NCT01470183 - Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients N/A
Terminated NCT00089804 - Study of LJP 394 in Lupus Patients With History of Renal Disease Phase 3