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New treatment option for Rheumatoid Arthritis (RA)
Official title COMFI - a COMbined Fatigue Intervention
ClinicalTrials.gov ID: NCT06666452
What this study is testing
- What it's testing
- Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.
- Must have experienced fatigue as a challenge for at least the last 3 months
- A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis
- The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in...
- Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.
You likely can't join if
- Pregnant or breastfeeding
- Critical/serious illness:
- Diseases with an expected survival of \< 2 years (e.g., cancer)
- Heart failure with NYHA class 3 or 4
- Kidney failure with eGFR \< 30
- Severe anemia - hemoglobin ≤ 5.0 mmol/L
See the full eligibility criteria
- Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.
- Must have experienced fatigue as a challenge for at least the last 3 months
- A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis
- The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in treatment in the last 3 months (DMARDs or steroids) incl. steroid...
- Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.
- Age ≥18 years.
- Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.
- The participant must be interested in actively participating and making changes to daily life to improve their condition.
- Pregnant or breastfeeding
- Critical/serious illness:
- Diseases with an expected survival of \< 2 years (e.g., cancer)
- Heart failure with NYHA class 3 or 4
- Kidney failure with eGFR \< 30
- Severe anemia - hemoglobin ≤ 5.0 mmol/L
- Clarification of known diseases, which must be well-treated or in remission:
- Diabetes: HbA1c \>53 mmol/mol is excluded if dysregulated
- Thyroid disease: TSH: 0.4-4.0 mE/L. Excluded if dysregulated
- A medical condition that would make the proposed interventions unsuitable/impossible for group participation or hinder the ability to give informed consent:
- Unstable psychiatric illness
- Dementia or other severe cognitive problems
- Hearing loss/use of hearing aids (it must be clarified how the person feels about being in a group setting)
- Other physical or mental conditions with the above effect
- Conditions that may be the primary cause of fatigue:
- Long-term effects after COVID-19
- Chronic fatigue syndrome
- Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE)
- Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue
- The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue
- If the participant cannot commit to attending on the scheduled dates in one of the two programs.
The study team makes the final eligibility decision.
Where it's taking place
- Sønderborg, Denmark, Denmark
- Lund, Sweden, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sønderborg, Denmark, Denmark; Lund, Sweden, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.