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
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
1 other identifier
interventional
6,610
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 14, 2007
CompletedFirst Posted
Study publicly available on registry
March 16, 2007
CompletedAugust 4, 2008
July 1, 2008
2.2 years
March 14, 2007
July 31, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Change of disease activity score (DAS28) compared with study entry
Week 12
EULAR and ACR response criteria at week 12
Week 12
Secondary Outcomes (2)
Adverse events
Baseline - Week 12
Clinical laboratory parameters
Screening, Week 6 & Week 12 and/or ET
Study Arms (1)
1
EXPERIMENTALOpen-label adalimumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Related Publications (3)
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PMID: 27338778DERIVEDBurmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.
PMID: 24460746DERIVEDBurmester GR, Ferraccioli G, Flipo RM, Monteagudo-Saez I, Unnebrink K, Kary S, Kupper H. Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. Arthritis Rheum. 2008 Jan 15;59(1):32-41. doi: 10.1002/art.23247.
PMID: 18163417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Beverly Paperiello
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2007
First Posted
March 16, 2007
Study Start
September 1, 2002
Primary Completion
November 1, 2004
Last Updated
August 4, 2008
Record last verified: 2008-07