Thiamine Against Chronic Rheumatoid Arthritis Fatigue

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 21.0Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859; MedDRA version: 21.0Level: LLTClassification code: 10062719Term: Seronegative rheumatoid arthritis Class: 10028395; MedDRA version: 21.0Level: LLTClassification code: 10040107Term: Seropositive rheumatoid arthritis Class: 10028395; MedDRA version: 21.1Level: LLTClassification code: 10003268Term: Arthritis rheumatoid Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2022-500922-13-00
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study Completion: 2023-08-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Rheumatoid arthritis diagnosed > 3 months ago., In remission/mild disease activity (CRP < 10 mg/l, MD-HAQ < 1,3, DAS28 < 3,2), Chronic fatigue (duration of fatigue = 6 months, BRAF total fatigue score = 16), Age =18 years, Signed informed consent, Anticontraceptive (People who can get pregnant will need to use a safe anticontraceptive during the trial (12 weeks). Safe anticontraceptive is defined as: combination pills, intrauterine device, depot injection, subdermal implant, hormonal vaginal ring, or transdermal depot patch)

Exclusion Criteria

Patients with co-morbidity which can explain the participants fatigue, including: Anaemia (haemoglobin < 7,1 mmol/l [female]; < 8,1 mmol/l [male], Iron deficiency (Ferritin < 30 µg/l), Vitamin B12 deficiency (Vitamin B12 <125 pmol/l), Folate deficiency (Folate < 9 nmol/l), Vitamin D deficiency (25-Hydroxy-Vitamin D[D3+D2] < 50 nmol/l), Diabetes (HbA1c = 48 mmol/mol or medication), Hypo/hyperthyroidism (TSH <0,300 or > 4,5 IU/l or medication), Participants who are unable to cooperate and follow the protocol, Pregnant patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to investigate the efficacy of 4 weeks of high dose oral thiamine as treatment for chronic fatigue in patients with rheumatoid arthritis. The primary outcome is a change in fatigue level immediately after 4 weeks of treatment, measured using the Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ).;Secondary Objective: To investigate the patients’ quality of life during the study period., To investigate the association between fatigue levels, thiamine levels and lactate concentration in the blood., To investigate possible side effects to the treatment.;Primary end point(s): A change in fatigue level immediately after 4 weeks of high-dose thiamine treatment. The minimal clinically important difference (MCID) is a decrease of 7,43 points or an increase of 2,58 points on the BRAF-MDQ total fatigue score.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):A change in the patients’ quality of life at week 4, 8 and 12. Difference in EQ-5D score, MCID of 0,04.;Secondary end point(s):A change in blood lactate concentration at week 4, 8 and 12.;Secondary end point(s):Side effects to the treatment.