Phase 2 N=137 Randomized Double-blind Treatment

Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

Lupus Nephritis · Lupus Erythematosus, Systemic

Bottom Line

View on ClinicalTrials.gov: NCT00774852 ↗

Enrolled (actual)

137

Serious AEs

39.4%

Results posted

Oct 2014

Primary outcome: Primary: Number of Participants With Complete Response — 22; 21 participants — p=0.85

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: abatacept (Drug); cyclophosphamide (Drug); azathioprine (Drug); prednisone (Drug); abatacept placebo (Drug); azathioprine placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Response	22; 21	0.85
SECONDARY Number of Participants With Partial Response	39; 40	0.99
SECONDARY Number of Participants With a Complete or Partial Response	12; 14; 13; 13	0.54
SECONDARY Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52	11; 13	0.54
SECONDARY Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response	22; 21	—
SECONDARY Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response	39; 42	—
SECONDARY Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study	0; 0	—
SECONDARY Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response	—	—
SECONDARY Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104	3; 3	>0.99
SECONDARY Lupus Disease Activity - Negative Anti-dsDNA	7; 10	>0.99
SECONDARY Lupus Disease Activity - Presence of Hypocomplementemia	12; 11; 11; 8	—
SECONDARY Lupus Disease Activity - Frequency of Flares	0; 2; 1; 3; 1; 0	0.23
SECONDARY Lupus Disease Activity - Patient Global Assessment	13.2; 18.7	—
SECONDARY Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline	26; -35.2	—
SECONDARY Lupus Disease Activity - SF-36 Scores	49.3; 45.3; 50.9; 49.2	—
SECONDARY Lupus Disease Activity - SF-36 Scores Percent Change From Baseline	32.1; 28.2; 39.6; 37.1	—
SECONDARY Lupus Disease Activity - Total BILAG-2004	1.8; 1.9; 3.2; 3.5	0.79
SECONDARY Proportion of Vaccinated Participants With a Competent Immune Response	67; 100; 50; 100	0.43

Summary

This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.

Eligibility Criteria

Inclusion Criteria

Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria
Active lupus nephritis (defined by: kidney biopsy documentation within the last 12 months using International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification- proliferative nephritis, active urinary sediment, urine protein-to-creatinine ratio > 1, low complement C3)
Positive antinuclear antibody (ANA) test result at time of study entry

Exclusion Criteria

End stage renal disease
Use of cyclophosphamide in the past year
Neutropenia, thrombocytopenia, moderately severe anemia
Active infection, including HIV, hepatitis B or C
History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
Pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00774852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.