Clinical trial NCT00639834: Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Official title: A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid
arthritis
RA
joint inflammation
autoimmune
Medarex
Rheumatology
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.


Eligibility criteria: Inclusion Criteria:

* Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
* Must have active RA
* Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
* All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration

Exclusion Criteria:

* Both Rheumatoid factor and anti-CCP negative
* Prior treatment with any B-cell depleting therapy
* Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
* History of or current inflammatory joint disease other than RA
* Neuropathies or neurovasculopathies that might interfere with pain evaluation
* Complications of RA or other disease
* Any other autoimmune disease other than RA
* Acute or chronic infection
* Clinically significant disease requiring

Primary outcomes:
measure: incidence and severity of treatment-emergent adverse events
timeFrame: all adverse events will be followed to resolution
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Sun Valley Arthritis Center LTD.
state: Arizona
city: Los Angeles
country: United States
facility: Impact Clinical Trials
state: California
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis (CRIA)
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research, Inc
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Baltimore
country: United States
facility: Good Samaritan Hospital and Johns Hopkins Hospital
state: Maryland
city: Lansing
country: United States
facility: Justus Fiechtner
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology, PLLC
state: Washington
city: Tacoma
country: United States
facility: George Krick, MD
state: Washington
city: Dresden
country: Germany
facility: Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
city: Koln
country: Germany
facility: klinikum der Universitat zu Koln
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU Munchen
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
city: Debrecen
country: Hungary
facility: DEOEC Kinikai Farmakologiai Tanszek
city: Szeged
country: Hungary
facility: First Department of Medicine
city: Donetsk
country: Ukraine
facility: V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
city: Kharkiv
country: Ukraine
facility: Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
city: Zaporizhya
country: Ukraine
facility: Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
city: Manchester
country: United Kingdom
facility: The Kellgren Centre for Rheumatology
city: Southampton
country: United Kingdom
facility: Welcome Trust Clinical Research Facility, Southampton General Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: