Status:
COMPLETED
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Abbott
Meda Pharmaceuticals
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomi...
Detailed Description
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patie...
Eligibility Criteria
Inclusion
- 1\. Patients (more than 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have had the diagnose \< 6 months.
- 2\. Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) \> 3.2.
- 3\. Negative pregnancy test (serum HCG) for women of childbearing potential prior to trial start. (Non-fertile women are defined as postmenopausal for at least 1 year or surgical sterilisation (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)). Fertile women included in the trial should use contraception during the entire trial period (i.e. one of the following methods: Oral contraception, intrauterine device (IUD), depot injection of progesterone, subdermal implantation, contraceptive vaginal ring, transdermal depot plaster). In addition, contraception should be used for a period of 150 days after any discontinuation of trial medicine.
- 4\. Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections.
- 5\. Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion
- 1\. Persons with latent TB defined with a positive Mantoux test (\>12 mm for vaccinated and 6 mm for non-vaccinated), positive cultivation of mycobacteria in tissue samples, chest X-ray indicating TB,or other risk factors for activation of untreated latent TB, and persons not been given adequate TB prophylaxis according to the instructions of the department.
- 2\. Active or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within the last 30 days or oral antibiotics within the last 14 days prior to inclusion
- 3\. Positive serology for Hepatitis B or C indicating active infection.
- 4\. Medical history with a positive HIV status (Check of HIV test upon suspicion).
- 5\. Medical history with histoplasmosis or listeriosis.
- 6\. Previous cancer or lymph proliferative disease except cases teated radically and have been without relapse for a minimum of 5 years.
- Patients with previous squamous cell carcinoma, basal cell skin carcinoma or cervical dysplasia, who have been treated successfully and radically can be included.
- 7\. Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, disturbed gait, facial paralysis, apraxia).
- 8\. Severe renal insufficiency (creatinine clearance \< 35 ml/min - nomogram).
- 9\. Affected liver function: Liver enzymes \> 2 x above normal limit value.
- 10\. Clinical significant drug or alcohol abuse during the past year and/or current daily alcohol consumption.
- 11\. Unstable diabetes, unstable ischemic heart disease, heart insufficiency (NYHA III-IV), active chronic inflammatory intestinal disease, recent cerebral apoplexia (within 3 months), chronic leg ulcer or any other condition (e.g. kateter a demeure)which according to the investigator imposes an increased risk to the subject, if he/she participates in the protocol.
- 12\. Anticoagulant therapy.
- 13\. Pregnancy or breast-feeding.
- 14\. Other inflammatory rheumatic diseases.
- 15\. Aggressive parvovirus B19 infection.
- 16\. Previous treatment with one or more DMARDs.
- 17\. Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids).
- 18\. Contraindications for trial medicine.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00660647
Start Date
September 1 2007
End Date
December 1 2011
Last Update
November 24 2015
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, DK-8000