An observational study in Rheumatoid Arthritis, Psoriatic Arthritis and Scleroderma, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Johns Hopkins University · Observational
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Among 975 studies in Arthritis, Rheumatoid with a site in United States — 82 open to participants now, 122 under way, 7 of them phase 3. Arthritis, Rheumatoid · United States.
Among the 975 studies in Arthritis, Rheumatoid with a site in United States, this one is the 192nd largest by enrollment of the 199 observational ones that give a count, is one of 31 that started in 2018, is one of 201 observational ones, and was the 716th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →82 of the 975 studies in Arthritis, Rheumatoid with a site in United States are open now. Recruiting first, the newest first:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
Ages 9–85 · Healthy volunteers
Bristol-Myers Squibb · Sites in United States, Belgium, Brazil and 8 more countries
Ages 18–65
Fate Therapeutics · Sites in United States
Ages 18–70
PTC Therapeutics · Sites in United States, Georgia, Mauritius and 1 more country
Ages 18–70
University of Central Florida · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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975 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 161 · Phase 2 252 · Phase 3 172 · Phase 4 61
First in 1991; this study’s year is marked. 31 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 120 across the 771 interventional studies, 200 across the 199 observational. Of the 802 that completed or were terminated, 417 (52%) have results posted.
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629 of 975 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 8 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
38 of the studies in Arthritis, Rheumatoid with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06201416Sonoma Biotherapeutics, Inc.Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis | 2026-11 |
| NCT06628206LAPIX Therapeutics Inc.Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis | 2026-11-15 |
| NCT05961592Rise Therapeutics LLCR-2487 in Patients With Rheumatoid Arthritis | 2026-11-30 |
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
Add all 38 to your calendar (.ics) → With an account.
Among the 975 studies in Arthritis, Rheumatoid with a site in United States, from their registry updates:
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This study will assess the mental health and clinical benefits of Mindfulness Based Stress Reduction (MBSR) in patients with rheumatic disease who have anxiety or depression. MBSR, an interactive form of meditation that includes gentle yoga, will be taught by a certified instructor over an eight-week period. Mental health surveys will be conducted within one month of the study start and end as well as mid-course. Clinical assessments will be conducted within one-month of the study start and end.
Participation in the study entails completing a baseline and 1-month post MBSR follow up research appointment. A baseline research appointment must occur within 30 days (+/- 15 days) of the MBSR start. The 1 month follow up appointment must be completed within 30 days (+/- 15 days) after the MBSR course end. At each research appointment, disease activity, patient reported outcome measures (PROMs), and blood will be collected for future analysis. Patients will also be asked to complete the PROMs through an online survey platform using email, at MBSR course start, week 4 of the MBSR course, and at MBSR course end. Participants in the MBSR arm will also be recommended to perform self-directed meditation for 20-40 minutes per day, on off-days, throughout the 8-week session, as is typical for the MBSR course. Compliance with home meditation will be recorded on a take-home "practice" sheet that will be collected each week during the MBSR course.
If patients do not wish to participate in the MBSR course but are willing to participate in the study as a control, patients may also be consented. Controls will be asked to attend a baseline and 3-month research appointment where disease activity, PROMs, and blood donation would be obtained. Participants will also be asked to fill out PROMs (online) at 4 weeks. If a patient does not wish to participate in either arm of the MBSR study, patient will continue with routine psychological care for patient's anxiety and depression.
Blood samples will be collected at the baseline research appointment and the follow up research appointment, if the patient is willing. These samples will be drawn and banked for future analysis of inflammatory markers and cytokine expression.
Participants will be sent a health care usage survey after 3 months (coinciding with research visit 2; 1 month post-MBSR research visit or 3-month follow up research visit if control). Health care usage will continue to be screened for up to 1 year post research visit 1 via the electronic medical record.
Established patients of the Johns Hopkins Arthritis and Scleroderma Centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Inflammatory Arthritis (Rheumatoid Arthritis, Psoriatic Arthritis) and scleroderma participants in this group will attend an 8 week MBSR course. The MBSR course meets once per week for 2.5 hours with a 4-hour retreat on week 8.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
Rheumatoid Arthritis, Psoriatic Arthritis, and scleroderma participants in this group will watch an educational stress reduction video (10 minutes).
Other: Control
An interactive form of meditation that includes gentle yoga.
Standard of care including an educational video.
Change in anxiety
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale (8a). The PROMIS Anxiety Scale is measured as a t score with a t-score range from 41 (less anxious) to 80 (highly anxious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10.
Time frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
Change in Self-Efficacy (Symptoms)
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale 8a. The PROMIS Self-Efficacy (Symptoms) Scale is measured as a t score with a t-score range from 41 (less efficacious) to 80 (highly efficacious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10.
Time frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
Change in Self-Efficacy (Emotions)
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Scale 8a. The PROMIS Self-Efficacy (Symptoms) Scale is measured as a t score with a t-score range from 41 (less efficacious) to 80 (highly efficacious). For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10.
Time frame: Baseline, midcourse (approximately 4 weeks), post course (approximately 8-12 weeks)
Change in Clinical Disease Activity Index (CDAI)
The CDAI is calculated by the formula, CDAI = swollen joint count (28 sites) + tender joint count (28 sites) + patient global assessment (0-10; 10= severe) + evaluator global assessment (0-10; 10=severe). The total range is 0 to 76. Higher scores indicate more severe disease activity. Remission is considered less than 2.8, mild disease 2.8 to 10, moderate disease 10 to 22, and severe disease greater than 22.
Time frame: Baseline and post course (approximately 8-12 weeks)
Change in C-Reactive Protein (CRP)
A value of 0-0.5 mg/dL indicates a normal range. Values greater 0.5 mg/dL indicate elevated degrees of inflammation.
Time frame: Baseline and post course (approximately 8-12 weeks)
Change in Medsger Disease Severity Score (Composite Measure of Scleroderma Disease Activity)
The Medsger Severity Score is a composite measure for scleroderma disease activity comprised of the following sub-domains: general, peripheral vascular, skin, join/tendon, muscle, GI tract, lung, heart, kidney. Each sub-domain ranges from 0-4 (4=worse). The total Medsger Disease Severity Score is a sum of the subdomains and ranges from 0-36 (36= worse).
Time frame: Baseline and post course (approximately 8-12 weeks)
Plan to share: No
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Ran from Jan 2018 to primary completion in Apr 2021, 39 months.
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This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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