Rheumatoid arthritis
Conditions
Interventions
If DAS28 increased by >
0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
If DAS28 increased by >
0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
Sponsors
Leeds University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years old 2. Confirmed Participation by Informed Consent 3. Patients fulfilling the ACR/EULAR classification criteria 2010 for RA Patients must be: 4. Within the two years of starting on methotrexate AND 5. Within 5 years of diagnosis AND 6. In a stable clinical disease activity state (clinical remission/LDAS /other physician deemed state) on methotrexate (as monotherapy or combination +/- prednisolone 5mg oral daily) for at least 8 successive weeks before screening visit (with no change in DMARD +/- steroid therapy . see exclusion criteria). 7. Patients should be on an acceptable (maximal tolerated) MTX dose, which in the clinician's opinion, would justify escalation to adalimumab if a flare in disease activity occurs as detailed in the protocol. 8. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 5 months after study completion (or longer if on relevant therapy and in line with local regulations). Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 5 months after the end of the study period.
Exclusion criteria
Exclusion criteria: General 1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following randomisation. 2. Any persons that are committed to a psychiatric institution or in prison will be excluded from participation in this study. Study Specific 3. Patients with a secondary, non-inflammatory musculoskeletal condition (e.g., osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic 4. enough to interfere with evaluation of the effect of study drug or the patient's primary diagnosis of RA. 5. Patients with a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis) or connective tissue diseases, e.g. primary Sjogren's syndrome, systemic sclerosis, systemic lupus erythematosus, polymyositis. 6. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment) 7. Intramuscular, intra-articular or change in oral corticosteroid within 8 weeks of screening visit. 8. Oral Prednisolone dose > 5 mg within 8 weeks of screening 9. Unable to attend 12-weekly clinical assessments 10. Female patients who are breastfeeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following completion of the study. 11. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. Excluded Previous or Concomitant Therapy: 12. Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening. 13. Patients who have previously received any biological therapy for RA. 14. Immunisation with a live/attenuated vaccine within 4 weeks prior to baseline. 15. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in whom there is a decrease in synovial Doppler signal at week 48 after randomization | — |
Countries
Japan,Europe
Contacts
Public ContactMayumi Ito
EPS Associate Pharmaceutical Development Project Division
Outcome results
None listed