Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus (BUTTERFLY)

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 27, 2011
Last updated: December 14, 2015
Last verified: December 2015
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Condition Intervention Phase
Lupus Erythematosus, Systemic
Biological: PF-04236921
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint of the study is the proportion of subjects achieving the SLE Responder Index (SRI). [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with an improvement of greater than or equal to 4 in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with no new British Isles Lupus Assessment Group (BILAG) A organ domain scores or 2 new BILAG B organ domain scores [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with No worsening of Physician's Global Assessment (PhGA) score. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects who develop anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs), if observed. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in patient reported outcome measures using Short Form-36, European Quality of Life-5 Dimensional questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue and Visual Analog Scale scores. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving SRI at all timepoints except Week 24 [ Time Frame: week 4, 8, 12, 16, and 20 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving modified SRI at all timepoints [ Time Frame: week 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving BILAG based Combined Lupus Assessment (BICLA) response at all timepoints [ Time Frame: week 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with abnormal immunoglobulins, anti-dsDNA, C3, or C4 at baseline that become normal. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects receiving corticosteroids greater than 7.5 mg per day whose dose has been reduced by both >= 25% from baseline and to <= 7.5 mg per day during Week 12 through Week 24. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Evaluate the safety and tolerability of PF-04236921 at the different dose levels compared to placebo for adverse events, laboratory changes, ECGs, and vital signs. [ Time Frame: Week 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
  • Blood concentration of PF-04236921 [ Time Frame: Week 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: December 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
10 mg of PF-04236921 Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
50 mg of PF-04236921 Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
200 mg of PF-04236921 Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Placebo Biological: PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects between ages of 18 and 75 years old at time of signing consent.
  • Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
  • Have a unequivocally positive anti-nuclear antibody (ANA) test result.
  • Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

  • Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
  • Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01405196

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01405196     History of Changes
Other Study ID Numbers: B0151006  2011-000420-15  BUTTERFLY 
Study First Received: July 27, 2011
Last Updated: December 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases processed this record on May 24, 2016