In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2. MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: Humira (adalimumab)
Product Name: Humira® (adalimumab)
Product Code: 2593
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Sponsors
Aarhus University Hospital, Denmark
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (³ 18 years) with rheumatoid arthritis according to the ACR classification criteria (1) who have been diagnosed £ 6 months. Moderate to severe rheumatoid arthritis defined as DAS28 (CRP-based) > 3.2. 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 hystorectomy)). 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. Ability and willingness to inject the sc. injections him/herself or to have an assistant give the injections. Ability and willingness to give written informed consent and to meet the requirements of the trial protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Persons with latent TB (positive Mantoux test (>10 mm), positive inoculation of mycobacterium in tissue samples and/or chest X-ray indicating TB) or other risk factors for activation of untreated latent TB 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 Positive serology for Hepatitis B or C indicating active infection. Medical history with positive HIV status (Check of HIV test upon suspicion). Medical history with histoplasmosis or listeriosis. Previous cancer or lymph proliferative disease except from completely well treated squamous cell carcinoma, basal cell skin carcinoma or cervix dysplasia. Previous diagnosis or signs of demyelinized disease in the CNS system (e.g. optic neuritis, visual disorder, disturbed gait, facial paralysis, apraxia). Severe renal insufficiency (creatinine clearance 2 x above normal limit value. Clinical significant drug or alcohol abuse during the past year and/or current daily alcohol consumption. 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. catheter a demeure) imposing an increased risk on to the subject, if he/she participates in the protocol, as judged by investigator. Anticoagulant therapy. Pregnancy or breast-feeding. Other inflammatory rheumatic diseases. Aggressive parvovirus B19 infection. Previous treatment with one or more DMARDs. Glucocorticosteroid treatment within the last 4 weeks (except nasal and inhalation steroids). Contraindications for trial medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Inflammatory control as assessed primarily by number of patients who achieve a DAS28 < 3.2 after 12 and 24 months (Zero hypothesis: in early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is not better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.;Secondary Objective: In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab does not result in an improved outcome compared to methotrexate and intra-articular glucocorticoid alone as assessed by the development of joint erosions and cartilage), and In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab does not cause more adverse events including serious adverse events resulting in therapeutic consequences compared to methotrexate and intra-articular glucocorticoid alone). ;Primary end point(s): Assuming that 90% of patients treated with adalimumab and 70% of patients treated with placebo achieve the primary clinical endpoint (DAS < 3.2) after 12 and 24 months. Assuming that 90% of patients treated with adalimumab and 70% of patients treated with placebo achieve the primary radiographic endpoint (no radiographic progression) after 12 and 24 months. | — |
Countries
Denmark
Outcome results
None listed