Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: HUMIRA
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Route of administration of the placebo: Subcutaneous use
Sponsors
Helsingin reumakeskus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A diagnosis of RA according to the 1987 revised American College of Rheumatology (ACR) criteria 2) RA duration of 25 mm (VAS 10 cm) 8) Patient has been steadily in work-life for at least one year and is currently working or on sick-leave but not applying for pension 9) Patient feels that he/she will likely have to be off-work during the following 6 months due to his/her RA 10) Patient must be willing and able to provide written informed consent for the trial 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) A subject must not have a history of biological drug use for RA 2) A subject must not have evidence of active or latent tuberculosis, 3) A subject must not have any history of lymphoproliferative disease or malignancy within the previous 5 years 4) A subject must not have any other condition, that according to the investigator’s judgment makes him or her non-eligible for anti-TNF use 5) A subject must not have no inflammatory rheumatic disease other than RA 6) A subject must not have received any other investigational agents within 30 days prior to baseline visit, and must not receive them during the current trial 7) A female subject must not be pregnant or breast-feeding or planning pregnancy during the following year 8) A subject must not have had a major surgery within one month prior to study entry and must not have a scheduled operation during the 6-month follow up 9) A subject must not have any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the optimal participation in the trial. 10) A subject must not fulfill the criteria for reimbursement for biologics for RA and he/she would not normally be prescribed a biological drug according to physicians discretion and national treatment guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Randomized, controlled, double blind multi-center trial, main purpose is toa ssess whether a 6 months treatment adalimumab added on a conventional DMARD therapy will decrease the number of days on sick leave compared to placebo.;Secondary Objective: The cost-effectiveness and cost utility of the intervention compared to the conventional tretament.;Primary end point(s): Number of lost work days due to RA during the 6-month follow up. | — |
Countries
Finland
Outcome results
None listed