Efficacy, Safety, and Tolerability Study of Infliximab in Juvenile Spondyloarthropathies - Full Text View

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: ankylosing spondylitis

Drug Information available for: Infliximab

U.S. FDA Resources

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
A: Experimental 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.
B: Placebo Comparator Placebo	Drug: Placebo Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.

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

Anti-Inflammatory Agents
Spinal Diseases
Infliximab
Joint Diseases
Gastrointestinal Agents
Bone Diseases
Pharmacologic Actions

Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Antirheumatic Agents
Spondylarthritis
Dermatologic Agents
Spondylarthropathies

ClinicalTrials.gov processed this record on November 27, 2009