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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT01405196

Run by

Pfizer

People needed

183

Starts

2011-12-01

Expected to finish

2014-03-01

Last updated by the study team

2017-12-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Med Investigations, Inc. — Fair Oaks, California, United States
• Premier Clinical Research, LLC — Lakewood, California, United States
• Novo Research — Long Beach, California, United States
• St Mary Medical Center — Long Beach, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• UCLA Division of Rheumatology — Los Angeles, California, United States
• UCLA Rheumatology Clinical Research Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Inland Rheumatology and Osteoporosis Medical Group — Upland, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Asthma, Allergy, Arthritis and Lung Center — Daytona Beach, Florida, United States
• Southeastern Arthritis Center — Gainesville, Florida, United States
• Southeastern Community Pharmacy — Gainesville, Florida, United States
• Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute — Gainesville, Florida, United States
• Southeastern lmaging & Diagnostics — Gainesville, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Arthritis Associates — Orlando, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Advent Clinical Research Centers, Inc. — Pinellas Park, Florida, United States
• Anniston Medical Clinic, PC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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