Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients (AcceleRAte)

Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)

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 etanercept (ETA). The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (non-steroidal anti-inflammatory drug) over the first 12 weeks of treatment will be measured for primary outcome measured using a visual analogue scale (VAS) at week 12 compared to baseline between the two treatment groups.

Starting at week 12, the capability to taper corticosteroid (CS) treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups.

Study Overview

• Status: Completed
• Conditions: Rheumatic Arthritis
• Intervention / Treatment: Drug: Tofacitinib; Biological: Etanercept

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: Patients with active RA and lack of efficacy of at least one csDMARD treatment will be randomized to receive either TOFA or ETA. The study will be separated into two parts: The capability to decrease and discontinue pain-reducing treatment with a NSAID (Celecoxib, two times 200 mg as maximum standard dosage for RA) over the first 12 weeks of treatment will be measured for primary outcome. The proportion of patients with successful discontinuation of Celecoxib and significant and clinical relevant decrease of pain-levels measured using a visual analogue scale (VAS) with a reduction of at least 30% at week 12 compared to baseline will be compared between the two treatment groups.

Starting at week 12, the capability to taper CS treatment using a treat-to-target strategy, i.e. when at least low disease activity (LDA-DAS28) is achieved, will be measured in both groups. In addition to efficacy assessments (DAS28, ACR-response, SJC, TJC), patient reported outcomes, Quality of Life (QoL) measurements and patient satisfaction will be evaluated. Safety (severity and frequency of adverse events) will be evaluated over the 24-week treatment period.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin, Med. Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
  • Berlin, Germany
    • Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz
  • Frankfurt, Germany
    • CIRI - Centrum für innovative Diagnostik & Therapie, Rheumatologie/ Immunologie GmbH
  • Herne, Germany
    • Katholische Kliniken Rhein-Ruhr, St. Elisabeth Gruppe GmbH, Rheumazentrum Ruhrgebiet
  • München, Germany
    • Praxis Prof. Dr. Kellner
  • Ratingen, Germany
    • Rheumazentrum Ratingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tofacitinib; Tofacitinib (Xeljanz®; 5 mg twice daily, p.o.)	Drug: Tofacitinib; 5 mg twice daily, p.o.; Other Names: TOFA, Xeljanz
Active Comparator: Etanercept; Etanercept (Enbrel®; 50 mg once per week, s.c.)	Biological: Etanercept; 50 mg once per week, s.c.; Other Names: Enbrel, ETA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation of Celecoxib treatment and clinically relevant improvement in pain	Proportion of patients who can discontinue Celecoxib treatment and in whom clinically relevant improvement in pain levels are measured, defined as reduction in VAS pain of ≥ 30%	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean dosage of Celecoxib in patients	Mean dosage of Celecoxib in patients	at 12 weeks
discontinuation of CS-treatment	Proportion of patients with discontinuation of CS-treatment at week 24	at week 24
rescue treatment	Proportion of patients who require rescue treatment at week 12	at week 12
Mean dosage of Corticosteroids (CS) in the patients who achieve Low Disease activity (LDA) in the two treatment groups	Mean dosage of CS in the patients who achieve LDA at week 24 in the two treatment groups	at week 24
Mean dosage of Corticosteroids (CS)	Mean dosage of CS at week 24 (W24)	at week 24
NSAID treatment	Number of patients with NSAID treatment at W24	at week 24
re-started NSAID treatment	Proportion of patients who re-started NSAID treatment after week 12 (W12) until W24	week 12 to week 24
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 2
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 4
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 8
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 12
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 16
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 20
Absolute pain levels	Absolute pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 24
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 2
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 4
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 8
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 12
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 16
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 20
relative (percent) pain levels	relative (percent) pain levels measured by visual analogue scale (VAS). minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 24
Change in pain levels	Change in pain levels measured by visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 2
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 4
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 8
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 12
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 16
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 20
Change in pain levels	Change in pain levels visual analogue scale (VAS) compared to BL. minimum is 0 mm, maximum is 100 mm whereas 0 is no pain and 100 is worst	at week 24
Determination of flares	Determination of flares (measured by FLARE questionnaire) between week 12 and week 24	between week 12 and week 24
Proportion of LDA	Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)	at week 4
Proportion of LDA	Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)	at week 12
Proportion of LDA	Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)	at week 16
Proportion of LDA	Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)	at week 20
Proportion of LDA	Proportion of patients who achieve LDA (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) (DAS28 (ESR) ≤ 3.2)	at week 24
Proportion of DAS remission	Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)	at week 4
Proportion of DAS remission	Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)	at week 12
Proportion of DAS remission	Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)	at week 16
Proportion of DAS remission	Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)	at week 20
Proportion of DAS remission	Proportion of patients who achieve DASremission (Disease Activity Score 28 (DAS28) calculated by Erythrocyte sediment rate (ESR) DAS28 (ESR) ≤ 2.6)	at week 24
Proportion of ACR20 response	Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%	at week 4
Proportion of ACR20 response	Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%	at week 12
Proportion of ACR20 response	Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%	at week 16
Proportion of ACR20 response	Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%	at week 20
Proportion of ACR20 response	Proportion of patients who achieve ACR20 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 20%	at week 24
Proportion of ACR 50 response	Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%	at week 4
Proportion of ACR 50 response	Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%	at week 12
Proportion of ACR 50 response	Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%	at week 16
Proportion of ACR 50 response	Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%	at week 20
Proportion of ACR 50 response	Proportion of patients who achieve ACR50 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 50%	at week 24
Proportion of ACR 70 response	Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%	at week 4
Proportion of ACR 70 response	Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%	at week 12
Proportion of ACR 70 response	Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%	at week 16
Proportion of ACR 70 response	Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%	at week 20
Proportion of ACR 70 response	Proportion of patients who achieve ACR70 response - measure based on American College of Rheumatology (ACR) criteria improvement of at least 70%	at week 24
Changes in ACR core set	Changes in ACR core set	at baseline
Changes in ACR core set	Changes in ACR core set	at week 4
Changes in ACR core set	Changes in ACR core set	at week 12
Changes in ACR core set	Changes in ACR core set	at week 16
Changes in ACR core set	Changes in ACR core set	at week 20
Changes in ACR core set	Changes in ACR core set change	at week 24
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at baseline
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at week 4
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at week 12
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at week 16
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at week 20
DAS28 (ESR)	DAS28 (ESR) change compared to BL	at week 24
SJC (66),	Swollen joint count (66 joints) change compared to BL	at baseline
SJC (66),	Swollen joint count (66 joints) change compared to BL	at week 4
SJC (66),	Swollen joint count (66 joints) change compared to BL	at week 12
SJC (66),	Swollen joint count (66 joints) change compared to BL	at week 16
SJC (66),	Swollen joint count (66 joints) change compared to BL	at week 20
SJC (66),	Swollen joint count (SJC) (66 joints) change compared to BL	at week 24
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at baseline
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at week 4
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at week 12
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at week 16
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at week 20
TJC (68)	tender joint count (TJC) - 68 joints change compared to BL	at week 24
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores	at baseline
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores.SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 4
Change in Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 4
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 12
Change in Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 12
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 16
Change in Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 16
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 20
Change in Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 20
Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 scores. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 24
Change in Quality of Life: SF36 (36 items short form health survey)	Quality of Life: SF36 change to BL. SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	at week 24
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at baseline
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 4
Change in Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 4
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 12
Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 12
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 16
Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 16
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores.The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 20
Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 20
Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI scores. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 24
Change of Quality of Life HAQ-DI (health assessment questionnaire - disability index)	Quality of Life HAQ-DI change to BL. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do).	at week 24
Correlation of SF36 and HAQ-DI results	Correlation of SF36 and HAQ-DI results. The HAQ-DI is a health assessment questionnaire - disability index that consists of 8 subcategories. For each the single scales range from 0 (no difficulty) to 3 (unable to do). SF36 is a 36 items short form health survey and consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	through study completion, an average of 24 weeks
Treatment satisfaction: TSQM-14 scores	Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.	at week 4
Treatment satisfaction: TSQM-14 scores	Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.	at week 12
Treatment satisfaction: TSQM-14 scores	Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.	at week 16
Treatment satisfaction: TSQM-14 scores	Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores. The TSQM items are answered on 5- or 7-point Likert type scale and cover four domains: effectiveness; side effects; convenience and global satisfaction. A score can be obtained for each domain by summing of the corresponding items transformed on a 0-100 scale; higher values indicate higher satisfaction, better perceived effectiveness, lower burden associated to side-effects, better convenience.	at week 24
Patient's expectation on treatment	Patient's expectation on treatment asked and documented as free text	at baseline
Patient's expectation on treatment	Patient's expectation on treatment asked and documented as free text	at week 12
Patient's expectation on treatment	Patient's expectation on treatment asked and documented as free text	at week 24
Correlation of TSQM-14 results and patient's expectation on treatment	Correlation of TSQM-14 results and patient's expectation on treatment	through study completion, an average of 24 weeks
drug accountability	Evaluation of results of treatment adherence (drug accountability) using patient diary	at week 4
drug accountability	Evaluation of results of treatment adherence (drug accountability) using patient diary	at week 12
drug accountability	Evaluation of results of treatment adherence (drug accountability) using patient diary	at week 16
drug accountability	Evaluation of results of treatment adherence (drug accountability) using patient diary	at week 20
drug accountability	Evaluation of results of treatment adherence (drug accountability) using patient diary	at week 24
eGFR (estimated glomerular filtration rate)	eGFR value	at baseline
eGFR (estimated glomerular filtration rate)	eGFR value	at week 4
change in eGFR (estimated glomerular filtration rate)	eGFR change to BL	at week 4
eGFR (estimated glomerular filtration rate)	eGFR value	at week 12
change in eGFR (estimated glomerular filtration rate)	eGFR change to BL	at week 12
change in eGFR (estimated glomerular filtration rate)	eGFR change to BL	at week 16
eGFR (estimated glomerular filtration rate)	eGFR value	at week 16
change in eGFR (estimated glomerular filtration rate)	eGFR change to BL	at week 20
eGFR (estimated glomerular filtration rate)	eGFR value	at week 24
change in eGFR (estimated glomerular filtration rate)	eGFR change to BL	at week 24
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at baseline
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at week 4
change in blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL	at week 4
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at week 12
change in blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL	at week 12
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at week 16
change in blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL	at week 16
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at week 20
change in blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL	at week 20
blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure	at week 24
change in blood pressure (mmHg)	blood pressure (mmHg) Systolic or Diastolic Blood Pressure change to BL	at week 24
pain characteristics measured by QST (quantitative sensory testing)	Correlation of pain characteristics measured by QST, VAS pain and pain relief	at Baseline
pain characteristics measured by QST (quantitative sensory testing)	Correlation of pain characteristics measured by QST, VAS pain and pain relief	at week 4
pain characteristics measured by QST (quantitative sensory testing)	Correlation of pain characteristics measured by QST, VAS pain and pain relief	at week 8
pain characteristics measured by QST (quantitative sensory testing)	Correlation of pain characteristics measured by QST, VAS pain and pain relief	at week 12
pain characteristics measured by QST (quantitative sensory testing)	Correlation of pain characteristics measured by QST, VAS pain and pain relief	at week 24
adverse events (AEs)	Documentation of type, frequency and seriousness of adverse events (AEs)	through study completion, an average of 24 weeks
Infections	Incidence rates of serious infection events (SIEs),	through study completion, an average of 24 weeks
Documentation of all lab abnormalities	incidence rates of lab abnormalities	through study completion, an average of 24 weeks
Cardiovascular events	incidence rates of cardio vascular events	through study completion, an average of 24 weeks
Malignencies	incidence rates of malignancies	through study completion, an average of 24 weeks

Collaborators and Investigators

• Sponsor: Dr. Frank Behrens
• Collaborators: Pfizer
• Investigators: Principal Investigator: Harald Burkhardt, MD, Fraunhofer IME

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: pain; treat-to-target
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Arthritis; Rheumatic Fever; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Etanercept; Tofacitinib
• Other Study ID Numbers: TMP-0731-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No