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A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis (ReAct)

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: NCT00448383
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : August 4, 2008
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE March 14, 2007
First Posted Date  ICMJE March 16, 2007
Last Update Posted Date August 4, 2008
Study Start Date  ICMJE September 2002
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
  • Change of disease activity score (DAS28) compared with study entry [ Time Frame: Week 12 ]
  • EULAR and ACR response criteria at week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2007)
  • Change of disease activity score (DAS28) compared with study entry
  • EULAR and ACR response criteria at week 12
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
  • Adverse events [ Time Frame: Baseline - Week 12 ]
  • Clinical laboratory parameters [ Time Frame: Screening, Week 6 & Week 12 and/or ET ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2007)
  • Adverse events
  • Clinical laboratory parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
Official Title  ICMJE An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
Brief Summary This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: adalimumab
40mg every other week
Other Names:
  • ABT-D2E7
  • Humira
Study Arms  ICMJE Experimental: 1
Open-label adalimumab
Intervention: Biological: adalimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2008)
6610
Original Enrollment  ICMJE
 (submitted: March 14, 2007)
4000
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be 18 years or older
  • ACR criteria for diagnosis of RA for at least 3 months.
  • Active RA as defined by DAS28 >= 3.2 at study entry.
  • Unsatisfactory response or intolerance to prior DMARDs.
  • A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
  • Use of reliable method of contraception e.g. IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential. Male patients with procreative capacity should also ensure that effective contraception is used during the study and for 70 days after study completion

Exclusion Criteria:

  • Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
  • Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
  • Prior treatment with investigational biologic therapy (e.g. anti CD4)
  • Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
  • Prior treatment with total lymphoid irradiation
  • History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma.
  • History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
  • History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
  • Positive serology for hepatitis B or C indicating active infection
  • History of positive HIV status.
  • Persistent infection, or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
  • Female subjects who are pregnant or breast-feeding.
  • History of clinically significant drug or alcohol abuse in the last year.
  • Previous diagnosis or signs of demyelinating diseases
  • History of active tuberculosis (TB), histoplasmosis or listeriosis.
  • Signs of previous TB infection (chest X-ray signs or positive PPD skin test). The diagnosis of previous TB infection will be based on chest X-ray signs and on PPD skin test.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00448383
Other Study ID Numbers  ICMJE M02-497
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Larry McNamee, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Beverly Paperiello Abbott
PRS Account Abbott
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP