rheumatoid arthritis MedDRA version: 14.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870
Conditions
Interventions
Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concentration number: 40-
Trade Name: METHOT
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to give written informed consent and comply with the requirements of the study protocol. 2. Patients with active rheumatoid arthritis diagnosed for at least 6 weeks, but no more than 1 year, according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis 3. Patients naïve to treatment with MTX and that have received a prednisone dose ≤ 7,5 mg/d and a total prednisone dose ≤250 mg . 4. Swollen joint count (SJC) > 8 (66 joint count), and tender joint count (TJC) > 8 (68 joint count) at screening and baseline. 5. At screening CRP > 1.5 mg/dL (15 mg/L) or ESR ≥ 28 mm/h 6. ≥ 1 joint erosion or RF positivity or anti-CCP positivity 7. Age 18-70 years. 8. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline. 9. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation. 10. Must be willing to receive oral folate. Are the trial subjects under 18? no Number of subjects for this age range: 0 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: Exclusions related to RA 1.Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA is permitted. 2.Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis. 3.History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome). Exclusions Related to General Health 1.Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during the study. 2.Pregnancy or breastfeeding. 3.Significant and/or uncontrolled cardiac or pulmonary disease (including obstructive pulmonary disease). 4.Evidence of significant concomitant disease, including but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator's opinion, would preclude patient participation. 5.Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection. 6.Known active infection of any kind, or any major episode of infection requiring hospitalization or treatment with i.v.anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline. 7.History of serious recurrent or chronic infection. 8.History of previously untreated infection with mycobacterium tuberculosis or current treatment for it. **Latent TB infection is defined as: - a positive Mantoux Purified Protein Derivative (PPD) skin test using 10 IU of PPD (≥ 5 mm induration, regardless of BCG vaccination status) - chest radiograph with changes suggestive for TB infection (a chest radiograph will be performed at screening if not performed within 6 weeks prior to screening). These patients should be treated accordingly to local guidelines before entering the study. 9.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 10.Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g.Parkinsons disease, cerebral palsy, diabetic neuropathy 11.Any history or presence of congestive heart failure (CHF) (New York Heart Association classification for CHF: Class III or IV). 12.Any history of myocardial infarction within 5 years. 13.Cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormality, such as ischemia. 14.Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline. Exclusions Related to Medications 1.History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of adalimimab or methotrexate. 2.Previous treatment with MTX 3.Intra-articular or parenteral glucocorticoids within 4 weeks prior to baseline. 4.Intole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proportion of patients who achieve remission at 12 months, as defined by DAS 28 </= 2.6;Secondary Objective: 1. to evaluate the proportion of subjects who maintain stable remission at 24 months) after discontinuation of aggressive treatment 2. evaluation of ACR 20, 50, 70 (21) response at month 4, 8, 12 and 24 3. calculation of DAS 28 score at month 4, 8, 12 and 24 4. evaluation of clinical remission (DAS 28) at month 4, 8, 12 and 24 5. evaluation of HAQ at week 0, 4, 8, 12 and 24 6. evaluation of radiographic progression (Modified total Sharp score) (22) at months 12 and 24 7. evaluation of safety of different treatment regimens;Primary end point(s): remission induction in the intensively treated group vs control group treated with standard dosage of adalimumab and MTX | — |
Countries
Italy
Outcome results
None listed