Trial record 1 of 1 for:    NCT00448383
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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)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00448383
First received: March 14, 2007
Last updated: July 31, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change of disease activity score (DAS28) compared with study entry [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • EULAR and ACR response criteria at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Baseline - Week 12 ] [ Designated as safety issue: Yes ]
  • Clinical laboratory parameters [ Time Frame: Screening, Week 6 & Week 12 and/or ET ] [ Designated as safety issue: No ]

Enrollment: 6610
Study Start Date: September 2002
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Open-label adalimumab
Biological: adalimumab
40mg every other week
Other Names:
  • ABT-D2E7
  • adalimumab
  • Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00448383

Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larry McNamee, Abbott
ClinicalTrials.gov Identifier: NCT00448383     History of Changes
Other Study ID Numbers: M02-497
Study First Received: March 14, 2007
Last Updated: July 31, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on September 22, 2014