Rheumatoid Arthritis Clinical Trial
— TURAOfficial title:
Targeted Ultrasound in Rheumatoid Arthritis
Verified date | October 2019 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether therapy modifications (including addition of ultrasound-guided treatment change) can change imaging results in patients with early rheumatoid arthritis in a stable clinical disease activity state.
Status | Completed |
Enrollment | 183 |
Est. completion date | July 2019 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years old - Confirmed Participation by Informed Consent - Patients fulfilling the ACR/EULAR classification criteria 2010 for rheumatoid arthritis (RA) Patients must be: - Within the first year of starting on methotrexate AND - Within 5 years of diagnosis AND - In a stable clinical disease activity state (clinical remission/LDAS /other physician deemed state) on methotrexate (as monotherapy or combination +/= prednisolone 5mg oral daily) for at least 8 successive weeks (with no change in Disease-Modifying Anti-Rheumatic Drugs (DMARD) +/steroid therapy - see exclusion criteria) - Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 5 months after study completion (or longer if on relevant therapy and in line with local regulations). - Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 5 months after the end of the study period. Exclusion Criteria - Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment) - Intramuscular, intraarticular or change in oral corticosteroid within 8 weeks of screening visit. - Oral Prednisolone dose > 5 mg within 8 weeks of screening - Treatment with any investigational agent within 4 weeks (or 5 halflives of the investigational drug, whichever is longer) of screening. - Patients who have previously received any biological therapy for RA. - History of severe allergic or anaphylactic reactions to human, humanised or murine monoclonal antibodies - Evidence of serious +/uncontrolled concomitant disease which in the investigator's judgment would deem the patient inappropriate for inclusion in the study: including (but not exclusively)including cardiovascular (NYHA class III/IV heart failure), nervous system (demyelination), pulmonary (including obstructive pulmonary disease, pulmonary fibrosis), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.). - Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds). - Any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients with persistent infections and patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ). - Active TB requiring treatment within the previous 3 years. Patients should be screened for latent TB (as per local guidelines) and, if positive, treated following local practice guidelines prior to commencing the study. Patients previously treated for tuberculosis with no recurrence in 3 years are permitted. - Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation. 12. Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including haematological malignancies and solid tumours, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years unless related to primary disease under investigation. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | AbbVie, Theorem |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | GS (Grey Scale ultrasound)) at week 48 | Week 48 | ||
Other | X-ray scores at 48 and 96 weeks. | Weeks 48 and 96 | ||
Other | HAQ-DI scores at 48 and 96 weeks | Disability Index questionnaire | Weeks 48 and 96 | |
Other | Bone densitometry scores at weeks 48 and 96 | Weeks 48 and 96 | ||
Other | RA-WIS score at weeks 48 and 96 | Rheumatoid Arthritis Work Instability Scale | Weeks 48 and 96 | |
Other | EQ-5D score at weeks 48 and 96 | Quality of life questionnaire | Weeks 48 and 96 | |
Other | Proportion of patients requiring biological therapy at 48 and 96 weeks | Weeks 48 and 96 | ||
Other | Development of Co-Morbidity Evaluation. | Data collected will include total steroid exposure, number of infection events, blood pressure control. | Week 96 | |
Primary | Proportion of patients in whom there is a decrease in Power Doppler (PD) at week 48 after randomisation. | Week 48 | ||
Secondary | Total PD score at week 48 | Week 48 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |