Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006127-40-GB

Enrollment

Registered

2006-12-07

Start date

2007-09-16

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

Interventions

Trade Name: Humira Product Name: Humira 40mg solution for injection in pre-filled syringe (adalimumab) Pharmaceutical Form: Solution for injection INN or Proposed INN: recombinant human monoclonal ant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with active rheumatoid arthritis Comply with NICE criteria for treatment with TNF-alpha blockade Identified by consultant rheumatologist as eligible for treatment with TNF-alpha blockade Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contra-indications to MRI scanning Contra-indications to TNF-alpha blocakde (congestive cardiac failure, active/untreated tuberculosis, history of demyelinating disease, history of malignancy, presence of chronic infection) Female of child-bearing potential not using adequate contraceptive measures Prior treatment with TNF-alpha blockade Breast-feeding mothers

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To seek correlates between changes in cerebral blood flow and improvements in fatigue and psychometric function. To seek correlates between changes in cerebral blood flow and improvements in rheumatoid arthritis disease activity score.;Primary end point(s): Change in cerebral blood flow between week 0 and week 12 Change in Facit-fatigue scale between week 0 and week 12 Change in Disease Activity Score between week 0 and week 12 Change in psychometric testing between week 0 and week 12 ;Main Objective: To non-invasively study cerebral blood flow in a cohort of patients with rheumatoid arthritis, before and during TNF-alpha blockade	—

Measure

Time frame

Secondary Objective: To seek correlates between changes in cerebral blood flow and improvements in fatigue and psychometric function. To seek correlates between changes in cerebral blood flow and improvements in rheumatoid arthritis disease activity score.;Primary end point(s): Change in cerebral blood flow between week 0 and week 12 Change in Facit-fatigue scale between week 0 and week 12 Change in Disease Activity Score between week 0 and week 12 Change in psychometric testing between week 0 and week 12 ;Main Objective: To non-invasively study cerebral blood flow in a cohort of patients with rheumatoid arthritis, before and during TNF-alpha blockade

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026