A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Phase 1

• Conditions: Rheumatoid arthritis; MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2009-015740-42-DE
• Lead Sponsor: niversitätsklinkum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-12
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 318

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified