Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus - Full Text View

Sponsored by:	Rigel Pharmaceuticals
Information provided by:	Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00752999

Purpose

Approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to R788 or placebo. Patients will be followed for efficacy and safety parameters for 6 months. The investigator should taper corticosteroids if clinically warranted.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Fostamatinib Disodium (R935788) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease

Resource links provided by NLM:

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint is defined as the decrease from baseline in the SELENA-SLEDAI score at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite Responder analysis defined as ≥4 points improvement in SELENA-SLEDAI and no 'Severe SLE flare' after Week 6. No worsening (≤10 mm on VAS) of Physician Global Assessment, or, no worsening of SF 36 PCS (not >-0.8) or PFI (not >2.5) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Attainment of daily prednisone dose decrease in those patients on daily corticosteroids by 50% or to ≤ 7.5 mg prednisone (or equivalent for other corticosteroids) at 3 and 6 months. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Decrease from baseline in SELENA-SLEDAI score at each post baseline visit. [ Time Frame: At each post baseline visit ] [ Designated as safety issue: No ]
Attainment of improvement in SELENA-SLEDAI by ≥ 2 points at Weeks 2 and 4. [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Attainment of improvement in SELENA-SLEDAI by ≥ 4 points at each post baseline visit. [ Time Frame: At each post baseline visit ] [ Designated as safety issue: No ]
Change from baseline of Physician Global Assessment by VAS over 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to rescue medication. [ Time Frame: At each post baseline visit ] [ Designated as safety issue: No ]
Time to severe SLE flare by SELENA Flare Index. [ Time Frame: At each post baseline visit ] [ Designated as safety issue: No ]
Change from baseline in the component scores of the SF 36 at Month 3 and Month 6. [ Time Frame: Month 3 and 6 ] [ Designated as safety issue: No ]
Effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I adverse effects, new onset or aggravated hypertension, and other adverse effects as they may appear. [ Time Frame: At each post baseline visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

225

Arms	Assigned Interventions
A: Experimental 150 mg tablet, oral, twice-a-day	Drug: Fostamatinib Disodium (R935788) 150 mg tablet, oral, twice-a-day
B: Placebo Comparator Placebo tablet, oral, twice-a-day	Drug: Placebo Placebo tablet, oral, twice-a-day

Detailed Description:

This study is a multi-center, multinational, randomized, double-blind, placebo-controlled Phase II clinical trial. Study enrollment will comprise approximately 225 patients meeting study inclusion requirements. The study will be conducted at up to 80 multinational investigational sites. Eligible patients will be randomized (2:1) into one of two 6 month treatment groups. One group (approximately 150 patients) will receive R788 150 mg PO bid; the other treatment group (approximately 75 patients) will receive placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must give written informed consent to participate in this study by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study.
Males and females, 18 years of age or older, with active SLE diagnosed at least 6 months prior to Day 1 dosing. Active SLE is defined as having fulfilled the ACR criteria for SLE.
Patients of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use an effective method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent).
The patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period.
In the investigator's opinion, the patient has the ability to understand the nature of the study and any anticipated risks of participation, communicate satisfactorily with the investigator, and participate in and comply with the requirements of the entire protocol.

Exclusion Criteria:

The patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
Clinically significant or uncontrolled medical disease in any organ system, other than due to SLE.
Background immunosuppressive therapy that has not remained stable ≤ 4 weeks prior to baseline.
Severe active or unstable renal disease.
Active severe neuropsychiatric SLE.
Female patients must not be breastfeeding and must have a negative urine pregnancy test per the Schedule of Study Activities.
The patient has a history of substance abuse, drug addiction, or alcoholism.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752999

Sponsors and Collaborators

Rigel Pharmaceuticals

Investigators

Study Director:

Daniel B. Magilavy, MD

Rigel Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Rigel Pharmaceuticals, Inc. ( Daniel B. Magilavy, MD/Vice President, Clinical Development )
Study ID Numbers:	C-935788-015, EudraCT No. 2008-004472-50
Study First Received:	September 15, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00752999 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rigel Pharmaceuticals:

SLE
Lupus

Study placed in the following topic categories:

Autoimmune Diseases
Lupus Erythematosus, Systemic
Lupus
Connective Tissue Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 02, 2009