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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01405196
First received: July 27, 2011
Last updated: December 14, 2015
Last verified: December 2015
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • 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 ]
  • Percentage of subjects with No worsening of Physician's Global Assessment (PhGA) score. [ Time Frame: week 24 ]
  • Percentage of subjects who develop anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs), if observed. [ Time Frame: week 24 ]
  • 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 ]
  • Proportion of subjects achieving SRI at all timepoints except Week 24 [ Time Frame: week 4, 8, 12, 16, and 20 ]
  • Proportion of subjects achieving modified SRI at all timepoints [ Time Frame: week 4, 8, 12, 16, 20, and 24 ]
  • Proportion of subjects achieving BILAG based Combined Lupus Assessment (BICLA) response at all timepoints [ Time Frame: week 4, 8, 12, 16, 20, and 24 ]
  • Percentage of subjects with abnormal immunoglobulins, anti-dsDNA, C3, or C4 at baseline that become normal. [ Time Frame: week 24 ]
  • 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 ]
  • 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 ]
  • Blood concentration of PF-04236921 [ Time Frame: Week 4, 8, 12, 16, 20, and 24 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405196

  Show 113 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01405196     History of Changes
Other Study ID Numbers: B0151006
2011-000420-15 ( EudraCT Number )
BUTTERFLY ( Other Identifier: Alias Study Number )
Study First Received: July 27, 2011
Last Updated: December 14, 2015

Keywords provided by Pfizer:
double-blind
placebo-controlled
multicenter
dose-ranging
efficacy
safety
lupus.

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017