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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00591201
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : January 17, 2008
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Hospital General de Mexico

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.


Condition or disease Intervention/treatment Phase
Spondylarthropathies Drug: infliximab Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : June 2002
Actual Primary Completion Date : June 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of joints with active arthritis. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591201


Locations
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Mexico
Servicio de Reumatología, Hospital General de México
México City, DF, Mexico, 06720
Sponsors and Collaborators
Hospital General de Mexico
Schering-Plough
Investigators
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Principal Investigator: Rubén Burgos-Vargas, MD Rheumatologist, Hospital General de México/Professor of Medicine, Universidad Nacional Autónoma de México
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Responsible Party: Rubén Burgos-Vargas/Professor of Medicine, Medical Doctor., Hospital General de México and Universidad Nacional Autónoma de México
ClinicalTrials.gov Identifier: NCT00591201    
Other Study ID Numbers: HGMREUMA.001.2007
DIC/02/404-B/02/036
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: December 2007
Keywords provided by Hospital General de Mexico:
Spondylarthritis
TNF
Infliximab
Ankylosing spondylitis
Juvenile SpA
Juvenile arthritis
Additional relevant MeSH terms:
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Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents