A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007

• Conditions: systemic lupus erythematosus; MedDRA version: 9.1Level: LLTClassification code 10042945Term: Systemic lupus erythematosus

• Registration Number: EUCTR2007-002566-35-GB
• Lead Sponsor: CB Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Male or female patients aged equal to or greater than 18 years of age at Visit 1 (screening).
2. Signed written informed consent prior to the initiation of any study-specific assessment at Visit 1 (screening).
3. Adequate reading and writing abilities (in their native language) such that the patient can comprehend and answer the questions on the patient completed assessments.
4. Positive ANA result at Visit 1 (screening) either via screening or confirmatory central laboratory testing methodologies.
5. Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 (not including Neurologic Disorder) of the 11 criteria are met. If positive for Neurologic Disorder criteria, a total of 5 of the 11 ACR criteria must be met.
6. Active moderate or severe SLE disease activity as demonstrated by BILAG A level disease activity in at least one body/organ system (except renal or neurological) or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present. At least one of the BILAG A scores OR at least two of the BILAG B scores must be in the following categories: Mucocutaneous, Musculoskeletal or Cardiovascular/ Respiratory.
7. Active moderate or severe SLE disease activity as demonstrated by SLEDAI total score of at least 6 at Visit 1 (screening).
8. If on antimalarials, must have been receiving antimalarials for at least 12 weeks, with a stable dose regimen for at least 28 days (-1 day) prior to Visit 2 and first study medication infusion and must be maintained at the same stable dose for the entire study.
9. If on immunosuppressives, must be on a stable dose for 28 days (-1 day) prior to Visit 2 and first study medication infusion and must be maintained at the same stable dose for the entire study. Maximum allowed doses for commonly prescribed immunosuppressives are listed in Table 10:1 of the protocol. Immunosuppressant must not include any immunosuppressants specifically mentioned in the exclusion medication table.
10. Receiving corticosteroids within the range of 5 to 60 mg/day prednisone (or equivalent) at a stable dose for at least five days (-1 day) prior to Visit 2 and the first study drug infusion, with the corticosteroid dose dependent on the investigator’s assessment of disease severity. If steroids are initiated or increased for current disease flare, this increase must not have occurred more than 14 days (-1 day) prior to Visit 2 and the first infusion of study medication. Use of IV (including high pulse doses of IV Solu-Medrol), IM or IA injections of corticosteroids are not allowed at any time during the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Active, severe neuropsychiatric SLE including but not limited to BILAG A criteria as follows: existing Aseptic meningitis, Cerebral vasculitis, Demyelination syndromes (including ascending or transverse myelitis and Acute inflammatory demyelinating polyradiculoneuropathy), Myelopathy, Acute confusional state, Impaired level of consciousness, Psychosis, Cranial neuropathy, Plexopathy, Grand mal seizure, Status epilepticus, Cerebellar ataxia, Stroke or stroke syndrome, chorea or any other severe neurologic condition which, in the opinion of the investigator, would prevent the subject from completing protocol required procedures. Mononeuritis multiplex is NOT excluded provided it is not new (within the past 4 weeks).
2. Active severe SLE disease activity which involves the Renal system or serum creatinine >2.5mg/dL or clinically significant (per investigator judgment) serum creatinine increase within the 28 days (-1 day) prior to Visit 1 or proteinuria > 3.5gm/day.
3. Female subjects who are pregnant or lactating. Women of childbearing potential are required to have a serum pregnancy test taken at Visit 1 which is confirmed to be negative prior to the first dose of study medication at Visit 2. Additionally, a urine pregnancy test will be completed prior to all remaining doses and must be negative in order for the subject to receive the study drug. Urine pregnancy tests will then be repeated every 4 weeks and at the Follow up Visit. Women of childbearing potential must use an acceptable method of birth control during the trial and for a period of 3 months after the last dose of study medication. Acceptable forms of birth control include oral contraceptives [which must be stable for at least one full month prior to Visit 1and should remain stable during the study], double barrier methods and the single-barrier methods of diaphragm with adjunct spermacide or condom with adjunct spermacide. Unacceptable methods include abstinence alone or condoms/diaphragm use without adjunct spermacide. Women not receiving birth control must be surgically sterile (hysterectomy/oophrectomy or tubal ligation) or postmenopausal for at least 2 years prior to (Visit 1) screening.
4. Evidence of an immunosuppressive state including HIV infection, agammaglobulinemias, T-cell deficiencies or HTLV-1 infection at any time prior to or during the study.
5. Patients with a history of chronic infections including, but not limited to hepatitis B or C. Patients with a history of recent, serious or life-threatening infection (e.g. pneumonia or herpes zoster) or any current sign or symptoms that may indicate a significant infection at Visit 1 (screening) as per the Investigator’s clinical judgment. Patients must have completed any antibiotics prior to the first dose of study medication.
6. Patients who in the opinion of the principal investigator are at a particularly high risk of significant infection due to their lifestyle, occupational or social contacts.
7. Substance abuse/dependence or other concurrent medical conditions that could confound study interpretation or affect the patient’s ability to fully participate in the study.
8. Patients receiving any vaccination (including live attenuated, toxoid and subunit) within 14 days prior toVisit 1 (screening) or during the course of the study. Influenza and human papillomavirus vaccines are allowed prior to study entry but are prohibited during the study. Tetanus vaccines are allowed prior to study entry and during the s

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified