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Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies
This study has been completed.

First Received on December 31, 2007.   Last Updated on January 16, 2008   History of Changes
Sponsor: Hospital General de Mexico
Collaborator: Schering-Plough
Information provided by: Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT00591201
  Purpose

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.


Condition Intervention Phase
Spondylarthropathies
Drug: infliximab
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of Infliximab (Remicade; Schering-Plough) in Juvenile Spondyloarthropathies: a Three-Month, Randomized, Double-Blind, Placebo-Controlled Trial and 52-Week Open Extension.

Resource links provided by NLM:


Further study details as provided by Hospital General de Mexico:

Primary Outcome Measures:
  • Number of joints with active arthritis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of tender entheses; patient assessment of pain; patient/parent assessment of well being; investigator assessments of disease activity and health status; childhood health assessment questionnaire; and C reactive protein. Safety issues [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: June 2002
Study Completion Date: September 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Infliximab
Drug: infliximab
Infliximab 5mg/kg diluted in 250 ml of isotonic solution of sodium chloride will be administered by the intravenous route on weeks 0, 2, 6, 12, 18, 24, 30, 36, 42, and 48.
Other Name: remicade
Placebo Comparator: B
Placebo
Drug: Placebo
Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591201

Locations
Mexico
Servicio de Reumatología, Hospital General de México
México City, DF, Mexico, 06720
Sponsors and Collaborators
Hospital General de Mexico
Schering-Plough
Investigators
Principal Investigator: Rubén Burgos-Vargas, MD Rheumatologist, Hospital General de México/Professor of Medicine, Universidad Nacional Autónoma de México
  More Information

No publications provided

Responsible Party: Rubén Burgos-Vargas/Professor of Medicine, Medical Doctor., Hospital General de México and Universidad Nacional Autónoma de México
ClinicalTrials.gov Identifier: NCT00591201     History of Changes
Other Study ID Numbers: HGMREUMA.001.2007, DIC/02/404-B/02/036
Study First Received: December 31, 2007
Last Updated: January 16, 2008
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital General de Mexico:
Spondylarthritis
TNF
Infliximab
Ankylosing spondylitis
Juvenile SpA
Juvenile arthritis

Additional relevant MeSH terms:
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2012