Recent Updates
Recently added Catalysts

MDX-1100

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Apr 23, 2010

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

MDX-1100 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01017367Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED70 Analytics
PHASE2COMPLETED
Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

ACR 20 Response rate
85 days
incidence and severity of treatment-emergent adverse events
events will be followed to resolution

Secondary Endpoints

Safety and tolerability will be monitored by physical exam, laboratory tests, electrocardiograms, chest x-ray and adverse events experienced and reported by the patient
141 days
vital sign measurements
study duration - each visit
clinical laboratory tests
study duration - each visit
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MDX-1100EXPERIMENTALMDX-1100 10 mg/kg administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71
PlaceboPLACEBO_COMPARATORPlacebo (saline) administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71
1EXPERIMENTALpatients will receive active MDX-1100

Interventions

NameTypeDescription
MDX-1100DRUGMDX-1100 10 mg/kg i.v. over 60 minutes on days 1, 15, 29, 43, 57 and 71
PlaceboDRUGPlacebo
MDX-1100 (anti-CXCL10 human monoclonal antibody)DRUGPatients will receive a single dose of MDX-1100 at 0.3, 1.0, 3.0 or 10 mg/kg as a 60 minute intravenous infusion. Patients who respond to treatment may receive up to an additional 3 doses of MDX-1100.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Must meet the ACR criteria for RA * Must have active RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints, and at least 2 of the following: a serum C-reactive protein level greater than the upper limit of normal, an erythrocyte sedimentation r...

Countries:RomaniaUkraineUnited States
Unlock Eligibility Criteria

Frequently asked questions about MDX-1100

What is MDX-1100 used for?

MDX-1100 is an investigational drug being studied for ulcerative colitis and rheumatoid arthritis. It is a small molecule developed by Bristol-Myers Squibb Company (BMY). Clinical trials have evaluated it in patients with active ulcerative colitis and in combination with methotrexate for active rheumatoid arthritis.

What does MDX-1100 target?

MDX-1100 targets CXCL10, as indicated by the trial title 'Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis.' It is a human monoclonal antibody directed against CXCL10, a chemokine involved in inflammatory processes.

Who makes MDX-1100?

MDX-1100 is developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical research on this investigational drug for autoimmune indications.

What phase is MDX-1100 in?

MDX-1100 is in Phase 2 clinical development. One completed Phase 2 trial evaluated it in combination with methotrexate for rheumatoid arthritis, and a Phase 1 trial in ulcerative colitis has also been completed. It remains investigational and is not FDA approved.

What clinical trials is MDX-1100 in?

MDX-1100 has been studied in two completed trials: NCT00295282, a dose-escalation study in patients with active ulcerative colitis (Phase 1, 24 participants), and NCT01017367, a Phase 2 study in combination with methotrexate for active rheumatoid arthritis (70 participants). Both trials are completed.

Is MDX-1100 the same as an anti-CXCL10 antibody?

Yes, MDX-1100 is an anti-CXCL10 human monoclonal antibody. This is confirmed by the official trial title for the rheumatoid arthritis study, which describes MDX-1100 as an anti-CXCL10 human monoclonal antibody. It is being investigated for its role in inflammatory conditions.