Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Tumor necrosis factor (TNF) alpha is a pro-inflammatory cytokine playing a significant role in the pathogenesis of the spondyloarthropathies (SpA). Infliximab is a TNF alpha blocking monoclonal antibody efficacious and safe as treatment of adult-onset SpA.

In this study we will try to demonstrate that infliximab administered at 5mg/kg to patients with juvenile onset SpA over a period of 12 weeks will have more efficacy than placebo and that it will be well tolerated. At the end of this phase, patients will go into a 52-week open extension to demonstrate sustained efficacy, safety, and tolerability of infliximab We will include 34 patients with juvenile onset SpA unresponsive to standard treatment. Efficacy will be assessed by counting the number of actively inflamed joints and a number of other parameters.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General de Mexico
• Collaborator: Schering-Plough
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Ages less tha 16 years at symptoms onset and less than 18 years at entry

• SpA diagnoses (ESSG criteria)

• Active arthritis at least 2 peripheral joints

• Pressure tenderness at least 3 peripheral entheses

• Pain intensity of 40 mm in an analogue visual scale (VAS)

• Lack of response to NSAID, sulfasalazine or methotrexate

• Serum HCG-beta levels congruent with no pregnancy

• Use of double-barrier contraceptive methods

• History of BCG vaccination

• Capacity to understand the study and follow protocol instructions

• Written and signed consent letter.

Exclusion criteria:

• Pregnancy and lactation

• Mental disability

• Functional class IV

• Psoriasis, reactive arthritis or inflammatory bowel disease

• Infectious, neoplastic, metabolic, hepatic, hematological, vascular, cardiopulmonary or renal active diseases

• Opportunistic infectious

• Active tuberculosis

• Significant laboratory tests abnormalities

• Current prednisone dose of more than 10 mg/day;

• Intraarticular/muscular/venous glucocorticoids

• Previous use of Infliximab or etanercept, pentoxyphylline, thalidomide, or anti-CD4 antibodies

• Allergy or hypersensitivity to infliximab

• Significant drug changes within one month before screening

• Use of recreational drugs/illicit substances.