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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
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6610 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2002
Actual Primary Completion Date : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: 1
Open-label adalimumab
Biological: adalimumab
40mg every other week
Other Names:
  • ABT-D2E7
  • Humira

Primary Outcome Measures :
  1. Change of disease activity score (DAS28) compared with study entry [ Time Frame: Week 12 ]
  2. EULAR and ACR response criteria at week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Baseline - Week 12 ]
  2. Clinical laboratory parameters [ Time Frame: Screening, Week 6 & Week 12 and/or ET ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00448383

Sponsors and Collaborators
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Study Director: Beverly Paperiello Abbott
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Larry McNamee, Abbott
ClinicalTrials.gov Identifier: NCT00448383    
Other Study ID Numbers: M02-497
First Posted: March 16, 2007    Key Record Dates
Last Update Posted: August 4, 2008
Last Verified: July 2008
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents