Rheumatoid arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Prednisolon
Product Code: Prednisolon
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISOLONE
CAS Number: 50-24-8
Trade Name: Humira
Pharmaceutical Form: Injection
INN or Proposed
Sponsors
Universitätsklinkum Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Must understand and voluntarily sign an informed consent form • Must be able to adhere to the study visit schedule and other protocol requirements • Must be male or female and aged = 18 years at time of consent • Must have a diagnosis of RA according to ACR criteria for at least 12 months • Must have a DAS 28 score of less than 2,6 (means: remission) at randomization (documented continuously in two subsequent controls for six months) • At screening-visit patients should have been treated without alterations of therapy for at least six months with one of the following therapies: (i) one or more of the following conventional DMARDS: Methotrexate, Leflunomide, Ciclosporine A, Sulfasalazine, Azathioprine or Hydroxychloroquine, (ii) a combination of a conventional DMARD (Methotrexate, Leflunomide, Ciclosporine A, Sulfasalazine, Azathioprine or Hydroxychloroquine) with one of the following biologicals: Infliximab, Adalimumab, Etanercept, Tocilizumab, Golimumab, Certolizumab, (iii) or one of the biologicals mentioned above without combination with a conventional DMARD: Infliximab, Adalimumab, Etanercept, Tocilizumab, Golimumab, Certolizumab; all of them possibly combined with steroids. 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: • Treatment with Rituximab and/or Abatacept during the last 12 months before screening • Intake of a daily dosage of more than 5mg Prednisolone - equivalent during the last 6 months before randomization; intraarticular cortisone injections do not represent an exclusion criteria • Current treatment with other DMARDS (for example MMF or preparations still in development) than mentioned above • Any anti-inflammatory or immunosuppressive therapy for other reasons than RA during the last 3 months before screening • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study • Non-compliance • Any other rheumatological disease such as Psoriasis, SLE, PSS, MCTD, M. Bechterew, M. Behcet or M. Wegener. Should the respective diagnosis be confirmed after inclusion into the study the patient will leave the study and data is recorded via „unsceduled visit“ – and follow-up form. • Floride autoimmune conditions such as autoimmune hepatitis or Hashimoto’s disease while still under treatment • Participation in another phase 1-4 treatment study for RA • Pregnant or lactating female • Females of childbearing potential (FCBP is a sexually mature female who 1. has not undergone a hysterectomy or bilateral oophorectomy, or 2. has not been postmenopausal for at least 24 consecutive months) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception during the first 12 months of the study: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner. An occurred pregnancy is to be immediately reported to the investigating rheumatologist. The clinician will record the pregnancy via an SAE-form and start a therapy appropriate in cases of pregnancy. Patient who become pregnant during the course of the first 12 months of study leave the study yet data are reported continuously via the “Pregnancy”-form. • Males must report an occurred pregnancy of their partner immediately to the investigating clinician; this event does not represent an exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The current concept of RA-therapy is remission, which is defined by reaching a disease activity score counted in 28 joints of the body (DAS 28) of less than 2,6 as a main target. Rheumatoid Arthritis nowadays is being treated increasingly successful, due to better treatment with standard medications (dosage until limit, combination of therapies), due to quicker and more flexible therapy schemes (early start of treatment, close mashed therapy monitoring and due to introduction of new preparations. About 30% of RA patients reach clinical remission of RA. Yet it is still unclear, if and for how long a patient in long lasting and stable remission is to continue therapy or whether it is possible to reduce medication without risking a relapse of the disease. This study means on one hand to examine the possibility of a reduction of therapy or even a breaking off therapy in RA patients in long lasting remission.;Secondary Objective: On the other hand it is interesting to find out which factors might serve as predictory values for reaching and maintaining a long lasting remission in spite of reduction and/or breaking off of therapy.;Primary end point(s): Number of patients in each group still in remission after twelve months (DAS 28 < 2,6) | — |
Countries
Germany
Outcome results
None listed