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Active Juvenile Idiopathic Arthritis (JIA)Compassionate Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00775437
First received: October 17, 2008
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

The purpose of this research study is to determine if adalimumab is safe and effective in the treatment of patients with JIA who are 2 to <4 years old or age 4 and above weighing less than 15kg.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg With Active Juvenile Idiopathic Arthritis (JIA)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Incidence of SAEs and AEs of Interest [ Time Frame: Signing of consent through the 70 day follow-up call. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collection of PK data [ Time Frame: Baseline, Week 12, and Week 24 OR Early Termination visit. ] [ Designated as safety issue: No ]
  • Change from Baseline in laboratory findings [ Time Frame: Week 12, Week 24 OR Early Termination visit and every 12 weeks through the duration of the study. ] [ Designated as safety issue: No ]
  • PedACR30 [ Time Frame: Week 12, Week 24 and every 12 weeks through the duration of the study ] [ Designated as safety issue: No ]
  • PedACR50 [ Time Frame: Week 12, Week 24 and every 12 weeks through the duration of the study ] [ Designated as safety issue: No ]
  • PedACR70 [ Time Frame: Week 12, Week 24 and every 12 weeks through the duration of the study ] [ Designated as safety issue: No ]
  • PedACR90 [ Time Frame: Week 12, Week 24 and every 12 weeks through the duration of the study ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One Arm

One arm:

- for patients taking Humira

Drug: Adalimumab
Dosage based on Body Surface Area (BSA)
Other Name: Humira

Detailed Description:

This is a multicenter study for Subjects 2 to < 4 years of age and Subjects 4 years of age and above that weigh < 15 kg diagnosed with moderately to severely active polyarticular JIA or polyarticular course JIA. All adalimumab doses will be open label, and subjects will continue in the study for a minimum of 24 weeks, and then every 12 thereafter until reaching 15 kg and 4 years of age (or up to one additional year in the EU to allow transition to an appropriate treatment.

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed or before any medication is discontinued for the purpose of this study. The parent must also be willing to comply with all the requirements of this study protocol.
  2. Subject has a disease diagnosis of moderately to severely active polyarticular or polyarticular course JIA (defined as arthritis affecting > = 5 joints at the time of treatment initiation). This corresponds to the International League of Associations for Rheumatology categories of polyarticular rheumatoid factor positive (RF+), polyarticular Rheumatoid factor negative (RF-) disease, and extended oligoarthritis disease.
  3. Subject must be aged 2 to < 4 years old with moderately to severely active polyarticular JIA or polyarticular course JIA or age 4 or greater weighing < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA, per ILAR criteria.
  4. Subject is judged to be in generally good health as determined by the Investigator based upon the results of medical history, laboratory profile, and physical examination performed at Screening and confirmed at Baseline. This includes, but is not limited to, a normal cardiopulmonary and normal neurological exam result.
  5. Parent or legal guardian must be able and willing to administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
  6. Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary.
  7. Subject must have negative PPD test (or equivalent) at Screening. If subject has a positive (greater than or equal to 5mm induration) PPD test result, a chest x-ray (PA and lateral view) must be performed. If subject has a positive test (or equivalent), has had a post ulcerative reaction to PPD placement, and/or a chest x ray consistent with TB exposure, subject may not be enrolled into the study.
  8. For subjects in the EU, subject must have previously failed, had an insufficient response, or have been intolerant to at least one Disease-Modifying Anti Rheumatic Drug (DMARD).

Exclusion Criteria:

  1. Subject has had prior exposure to Tysabri® (natalizumab) or Raptiva® (efalizumab) or any other biologic therapy, such as Orencia® (abatacept), Kineret® (anakinra), Actemra® (tocilizumab), Rituxan® (rituximab). Any previous use of anti-TNF agents, including Enbrel® (etanercept), Remicade® (infliximab), Cimzia® (certolizumab pegol), Simponi® (golimumab), and adalimumab is also prohibited.
  2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
  3. Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study).
  4. Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
  5. Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab.
  6. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to Baseline visit. Should these biologics become approved, they would continue to be excluded.
  7. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, seizure disorder, and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
  8. Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia, a clotting disorder), renal, liver disease (e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer.
  9. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
  10. Subject has evidence of active TB infection.
  11. Subject has history of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident or thrombotic event and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
  12. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia).
  13. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of CNS demyelinating disease.
  14. History of invasive fungal infection (e.g., listeriosis, histoplasmosis), active viral disorders, human immunodeficiency virus (HIV) infection.
  15. Positive Hepatitis B test result.
  16. Chronic recurring infections or active TB.
  17. Screening laboratory and other analyses show any of the following abnormal results:

    • ECG - with clinically significant abnormalities;
    • Aspartate transaminases (AST) or alanine transaminase (ALT) > 1.75 the upper limit of the reference range;
    • Total bilirubin >=3 mg/dL;
    • Serum creatinine > 1.6 mg/dL (convert to mmol/L).
  18. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775437

Locations
United States, Arkansas
Site Reference ID/Investigator# 13803
Little Rock, Arkansas, United States, 72202
United States, District of Columbia
Site Reference ID/Investigator# 13901
Washington, District of Columbia, United States, 20010
United States, Florida
Site Reference ID/Investigator# 13721
Delray Beach, Florida, United States, 33484
Site Reference ID/Investigator# 13623
Miami, Florida, United States, 33155
United States, Georgia
Site Reference ID/Investigator# 15562
Atlanta, Georgia, United States, 30322
United States, Maryland
Site Reference ID/Investigator# 14501
Ellicott City, Maryland, United States, 21042
United States, Ohio
Site Reference ID/Investigator# 15563
Akron, Ohio, United States, 44308
Site Reference ID/Investigator# 15961
Cleveland, Ohio, United States, 44195
United States, Oregon
Site Reference ID/Investigator# 13483
Portland, Oregon, United States, 97227
Czech Republic
Site Reference ID/Investigator# 26102
Brno, Czech Republic, 61300
Site Reference ID/Investigator# 26103
Prague, Czech Republic, 120 00
Site Reference ID/Investigator# 30229
Prague 5, Czech Republic, 15006
France
Site Reference ID/Investigator# 26106
Paris, France, 75015
Germany
Site Reference ID/Investigator# 26109
Berlin, Germany, 13353
Site Reference ID/Investigator# 26107
Hamburg, Germany, 22081
Site Reference ID/Investigator# 26108
Sankt Augustin, Germany, 53757
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Hartmut Kupper, MD, MD AbbVie
  More Information

Additional Information:
No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00775437     History of Changes
Other Study ID Numbers: M10-444, 2009-013091-40
Study First Received: October 17, 2008
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Sweden: The National Board of Health and Welfare
Denmark: Ministry of Health
Denmark: Danish Medicines Agency
Spain: Ministry of Health

Keywords provided by AbbVie:
juvenile idiopathic arthritis
compassionate use
open label

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014