NCT00591201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

January 17, 2008

Status Verified

December 1, 2007

Enrollment Period

5 years

First QC Date

December 31, 2007

Last Update Submit

January 16, 2008

Conditions

Spondylarthropathies

Keywords

SpondylarthritisTNFInfliximabAnkylosing spondylitisJuvenile SpAJuvenile arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of joints with active arthritis.

    12 weeks

Secondary Outcomes (1)

  • 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

    12 weeks

Study Arms (2)

A

EXPERIMENTAL

Infliximab

Drug: infliximab

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

infliximabDRUG

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.

Also known as: remicade
A
PlaceboDRUG

Placebo -powder diluted in 250 ml of isotonic solution of sodium chloride- will be administered on weeks 0, 2 and 6.

B

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Reumatología, Hospital General de México

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

SpondylarthropathiesSpondylarthritisSpondylitis, AnkylosingArthritis, Juvenile

Interventions

Infliximab

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAxial SpondyloarthritisAnkylosisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Rubén Burgos-Vargas, MD

    Rheumatologist, Hospital General de México/Professor of Medicine, Universidad Nacional Autónoma de México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

June 1, 2002

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

January 17, 2008

Record last verified: 2007-12

Locations

ME(1)