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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib | Active Comparator | Tofacitinib (Xeljanz®; 5 mg twice daily, p.o.) |
|
| Etanercept | Active Comparator | Etanercept (Enbrel®; 50 mg once per week, s.c.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | 5 mg twice daily, p.o. |
|
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| 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 |
| 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 |
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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
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
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
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Harald Burkhardt, MD | Fraunhofer IME | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin, Med. Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie | Berlin | Germany | ||||
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two arm, randomized, open-label, parallel group
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| Etanercept | Biological | 50 mg once per week, s.c. |
|
|
| 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 |
| Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz |
| Berlin |
| Germany |
| CIRI - Centrum für innovative Diagnostik & Therapie, Rheumatologie/ Immunologie GmbH | Frankfurt | Germany |
| Katholische Kliniken Rhein-Ruhr, St. Elisabeth Gruppe GmbH, Rheumazentrum Ruhrgebiet | Herne | Germany |
| Praxis Prof. Dr. Kellner | München | Germany |
| Rheumazentrum Ratingen | Ratingen | Germany |
| ID | Term |
|---|---|
| D012213 | Rheumatic Fever |
| D010146 | Pain |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
| C014289 | 5-(tetradecyloxy)-2-furancarboxylic acid |
| D000068800 | Etanercept |
| D044022 | Receptor, Endothelin A |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D017466 | Receptors, Endothelin |
| D043562 | Receptors, G-Protein-Coupled |
| D018000 | Receptors, Peptide |
Not provided
Not provided