Rheumatoid arthritis and the muscle

Not Applicable

Completed

• Conditions: Sarcopenia and Rheumatoid Arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN13364395
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Protocol article in https://doi.org/10.22540/jfsf-08-053 (added 07/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-18
• Study Completion: 2023-03-31
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. 2010 ACR/ EULAR classification criteria for a diagnosis of rheumatoid arthritis
2. At least 6 months disease duration
3. Inadequate response to intensive therapy with synthetic disease-modifying anti-rheumatic drugs (DMARDs) alone, or inadequate response to at least one biologic DMARD, thereby qualifying for treatment with tofacitinib according to local guidelines.
4. Aged >18 years
5. Willing and able to provide written informed consent.
6. ACR Functional Class I-III
7. Willing to undergo muscle biopsy on 2 occasions.
8. Willing to undergo MRI and MRS and Dexa scan on 3 occasions
9. Active systemic disease, as exemplified by a C-reactive protein of at least 10 mg/l

Exclusion Criteria

1. Serum creatinine that is above the upper limit of normal at baseline.
2. Patients receiving glucocorticoids
3. Patients will be excluded if they have any contraindications to tofacitinib which include:
3.1 Pregnancy and lactation
3.2 Women of childbearing potential (WOCP) who are not prepared to use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose.
3.3 Severe hepatic impairment (Child Pugh C)
3.4 Active TB, serious infections such as sepsis or opportunistic infections as detailed in the SmPC
3.5 Chronic infections (HIV, hepatitis B, hepatitis C)
4. Participants will be excluded if they have any contraindications to muscle biopsies. These include:
4.1 Participants on anticoagulant therapy. These include vitamin K antagonists, thrombin inhibitors, and heparin and low molecular weight heparin preparations.
4.2 Participants on antiplatelet therapy. *Participants on aspirin for primary prevention will be included in this study. However, aspirin will be held for 7 days prior to the muscle biopsies and recommenced 48 hours after.
4.3 Participants who are known to have bleeding disorders. These include, but are not limited to, haemophilia, Factor II, V, VII, X, or XII deficiencies and Von Willebrand's disease
4.4 Previous reactions to local anesthetics
4.5 Platelets count < 100 x 109/l
5. Participants will be excluded if they have any contraindications to MRI. These include:
5.1 Limb metal pins, plates, rods of screws that were placed less than 6 weeks from scanning day
5.2 Heart pacemaker or replacement valves
5.3 Neuro-stimulator or programmable intra-cerebral shunt, cerebral aneurysm clips
5.4 Metallic foreign body in their eye
5.5 Internal hearing devices, ocular prosthesis
5.6 Weight >190 kg
5.7 Claustrophobia

Study & Design

• Study Type: Observational
• Study Design: Not specified