Status:
COMPLETED
Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients
Lead Sponsor:
Dr. Frank Behrens
Collaborating Sponsors:
Pfizer
Conditions:
Rheumatic Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Patients with active rheumatic arthritis (RA) and lack of efficacy of at least one csDMARD (Disease-modifying anti-rheumatic drug) treatment will be randomized to receive either Tofacitinib (TOFA) or ...
Detailed Description
In this clinical study, a design was chosen to reflect European standards recommended by EULAR for treatment of active RA by comparison of a Treat-to- target (T2T) approach in two treatment groups: Pa...
Eligibility Criteria
Inclusion
- Patients with active RA and an inadequate response to up to two previous conventional synthetic Disease modifying anti-rheumatic drug (csDMARD) treatments (methotrexate (MTX), leflunomide (LEF),sulfasalazine (SSZ)) with or without ongoing csDMARD therapy
- RA according to ACR classification criteria
- Age 18 - 65 years
- Active RA is defined as
- DAS28 \> 3.2 and
- TJC ≥ 3 and SJC ≥ 3
- VAS-pain ≥ 60 mm (0-100 mm)
- Accompanying CS treatment for RA with a stable dosage of ≥ 2mg/d and ≤ 10 mg/d 2 weeks prior to BL (not more than 30% of patients without CS)
- Accompanying need of NSAID or analgesic treatment due to arthritis and in dosages not exceeding the maximum dose according to Summary of Product characteristics (SmPC)
- If ongoing csDMARD treatment, stable treatment will be defined as either
- MTX treatment with a dosage of ≥ 10 mg/week and ≤ 25 mg/week, continuously for at least 12 weeks prior to Screening (SCR) with a stable dose of MTX for at least 2 weeks prior to BL or
- LEF treatment with a dosage between 10 to 20 mg/day, continuously for at least 12 weeks prior to SCR with a stable dose of LEF for at least 2 weeks prior to BL or
- SSZ treatment with dosage between 1 to 3 g/day, continuously for at least 12 weeks prior to SCR with a stable dose of SSZ for at least 2 weeks prior to BL
- Presence of documented negative results for testing of Hepatitis B and C
- Completed SARS-CoV-2-immunisation as currently recommended by the Standing Committee of Vaccination
- Written informed consent obtained prior to the initiation of any protocol-required procedures
- Willingness to comply to study procedures and study protocol
Exclusion
- Previous use of Tofacitinib or other Janus-Kinase (JAK)-inhibitors
- Previous use of Etanercept
- Previous use of any biological agent for RA
- which was stopped due to lack of efficacy
- one previous use of biological stopped due to intolerance will be allowed
- CS treatment with dosages \>10 mg at BL
- Known hypersensitivity to any component of the study medication (TOFA, ETA, Celecoxib)
- Previous use of Celecoxib as analgesic therapy which was stopped due to lack of efficacy or intolerance
- Concomitant diseases with chronic pain syndrome or need of extended dosages or long-term treatment with the maximum dosages of NSAID/analgesics (according to SmPC) due to other concomitant diseases/pain symptoms in discretion of the treating physician Exclusion criteria related to general health
- Patients with other chronic inflammatory articular disease or systemic autoimmune disease
- Patients with active Tuberculosis (Tb) (evaluation of Tb according to local standards in clinical care)
- Patients with latent Tb, that are not pre-treated for at least 1 month and planned to be treated 9 months in total with Isozid once a day
- Any active infection, a history of recurrent clinically significant infections (e.g. human immune deficiency virus (HIV)), or a history of recurrent bacterial infections with encapsulated organisms
- Primary or secondary immunodeficiency
- Current malignancy or history of malignancies except adequately treated or excised basal cell or squamous cell carcinoma or cervical carcinoma in situ.
- Patients of 50 years and older, if they have one or more cardiovascular risk factors (CVRF) defined as:
- Current cigarette smoking,
- Known diagnosis of hypertension,
- HDL \<40 mg/dl,
- Diabetes mellitus,
- History of coronary artery disease: history of revascularization procedure, coronary artery bypass grafting, myocardial infarction, cardiac arrest, unstable angina, acute coronary syndrome or
- History of premature coronary heart disease or sudden death documented in first degree relatives (male relative before 55 years, female relative before 65 years)
- Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and with the study outcome
- History of a severe psychological illness or condition
- Known hypersensitivity to sulfonamides
- Active peptic ulceration or gastrointestinal (GI) bleeding
- Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other NSAIDs including Cyclooxigenase (COX)-2 inhibitors
- Risk for or history of thrombotic events (e.g. pulmonary embolism or thrombosis) Severe hepatic dysfunction (serum albumin \< 25 g/L or Child-Pugh score ≥ 10)
- Patients with estimated creatinine clearance \< 30 mL/min
- Inflammatory bowel disease
- Congestive heart failure (New York Heart Association (NYHA) II-IV)
- Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
- Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, intrauterine device (IUD), physical barrier)
- Alcohol, drug or chemical abuse Exclusion criteria related to prior treatments
- Current participation in another interventional clinical trial or participation within the last 90 days Exclusion criteria related to formal aspects
- Underage or incapable patients
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04485325
Start Date
November 4 2019
End Date
March 31 2024
Last Update
August 28 2024
Active Locations (6)
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1
Charité Universitätsmedizin Berlin, Med. Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Berlin, Germany
2
Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz
Berlin, Germany
3
CIRI - Centrum für innovative Diagnostik & Therapie, Rheumatologie/ Immunologie GmbH
Frankfurt, Germany
4
Katholische Kliniken Rhein-Ruhr, St. Elisabeth Gruppe GmbH, Rheumazentrum Ruhrgebiet
Herne, Germany