Rheumatoid ArthritisREALISENCT05090124
Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE
A study testing Adalimumab in people with Rheumatoid Arthritis, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
Trial summary
The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Nov 2022to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years < 75 years.
- Physician diagnosed moderate to severe RA.
- No previous biologic disease modifying antirheumatic drug therapy
- Usual care physician has confirmed the patient is eligible for anti-TNF treatment for active RA in line with the license for adalimumab (originator or biosimilar) and local practice subject to satisfactory completion of standard pre-biologic safety screening. Standard pre-biologic safety screening includes but not limited to exclusion of latent TB infection according to local protocol, chest X-ray, negative HIV screen, negative Hepatitis screen antibody, negative Hepatitis B surface antigen [Hep B sAg] and negative Hepatitis B anti-core antibody [Hep B cAb]
- Note: Participant consent to treatment with adalimumab will have been obtained by the usual care team as per standard practice at site and will be prior to any approach for this study.
- Participant agrees to either immediate or delayed commencement of adalimumab.
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- Self-reported sickness behaviour (fatigue, depression, anxiety) with one component > 4 on NRS
- Right-handed (to reduce neuroimaging heterogeneity).
- Women of Child-Bearing Potential (WoCBP) must be willing to use of effective contraception for study duration. Further information is provided in appendix 1
- Willing to participate and give informed consent for this research study.
Who cannot join
- Inability to provide written informed consent.
- Severe physical impairment (e.g. blindness, deafness, paraplegia).
- Pregnant, planning pregnancy or breast feeding.
- Serious infection including sepsis, tuberculosis and opportunistic infections such as invasive fungal infections.
- Severe liver or renal disease.
- Clinically diagnosed major confounding neurological disease including Multiple Sclerosis, Stroke, Traumatic Brain Injury, Parkinson's Disease, Alzheimer's Disease or similar neurodegenerative disease.
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- Previous biologic disease modifying antirheumatic drug therapy with adalimumab, etanercept, qolimumab, infliximab, certolizumab, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib or upadacitinib.
- Recent (within 4 weeks prior to Visit 1 baseline) use of intra-muscular or intra-articular steroid injections.
- Contraindications to MRI (e.g. metal implants, claustrophobia).
- Contraindications to Adalimumab.
- Concurrent or previous use of any other medicinal product (excluding vaccinations) that may, in the Principal Investigator's opinion, influence underlying disease activity through effects on immune and/or inflammatory responses.
- If consenting to SPECT component, the following exclusions apply:
- Haemoglobin less than 100g/L
- Contraindications to SPECT protocol (e.g. hypersensitivity to Technetium or Stannous Chloride, recent Nuclear Medicine Procedure)
- Unwilling not to donate body fluids such as blood, sperm etc. for at least 24 hours after SPECT imaging at visits 1A and 4A.
- Unwilling to avoid close contact with children or people who are pregnant for 24 hours following SPECT imaging
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis
The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal studies. Data supporting the role of inflammatory molecules in sickness behaviours and other cognitive disorders are increasingly compelling. A putative mechanism linking inflammatory proteins to sickness behaviour is Tumour Necrosis Factor (TNF)-driven increases in extracellular glutamate leading to changes in neural function and brain network integrity and ultimately to sickness behaviour. Investigators hypothesise that TNF antagonism will effect changes in brain network connectivity and sickness behaviour score, that Rheumatoid Arthritis (RA) patients will show changes in brain network connectivity and glutamate quantification in the brain and that RA patients will show changes in monocyte infiltration into the brain that are correlated with changes in sickness behaviours. This is a randomised, placebo-controlled waiting list study. All patients will be eligible for anti-TNF treatment i.e. moderate to severe active disease as defined by Physician. Participants will be randomised to immediate (fast tracked) treatment or to treatment after 6-8 weeks (the routine waiting time). The latter group will receive placebo during the treatment phase.
Read the detailed description
The study will involve participants aged over 18 years with RA and are scheduled to start outpatient anti-TNF treatment (with Adalimumab) as part of standard clinical care, who meet the inclusion criteria and none of the specified exclusion criteria. All will give full informed consent. This is a single-blind, randomised placebo-controlled waiting list study and after screening and consent, eligible participants will be randomised (1:1) to receive either adalimumab or placebo.
The study comprises standard care screening for anti-TNF therapy (incorporated into the study to allow us to fast track screening), a total of 7 research visits and one remote visit via telephone. At Visit 1 (Day 0) and Visit 4 ((14 ± 2 days from Visit 3), participants will undergo 7T MRI and MRS Neuroimaging protocols that incorporate resting-state and task-based fMRI and glutamate MRS measures. At Visit 1A (1 - 7 days from Visit 1) and Visit 4A (1 - 7 days from Visit 4), participants will undergo an optional SPECT scanning protocol. This visit will involve a 160ml blood draw, from which monocytes will be isolated and radiolabelled before being reinjected prior to SPECT scanning.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab, Placebo
- Keywords
- Sickness Behaviour, Tumour Necrosis Factor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira, Amgevita, Imraldi, Hyrimoz
Adalimumab 40mg, will be administered as a subcutaneous injection once fortnightly on four occasions. The actual Adalimumab product selected at site will be dictated by what is used in standard care.
PlaceboDrug
Also called Sodium chloride 0.9% for injection
Sodium chloride 0.9% for injection will be used as a placebo. An equal volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection once fortnightly on four occasions.
| Study group | Role | What they receive |
|---|---|---|
| anti-TNF treatment | Experimental | Adalimumab 40mg, will be administered as a subcutaneous injection once fortnightly on four occasions. No dose adjustments are permitted. The actual Adalimumab product selected at site will be dictated by what is used in standard care.
The single-use, pre-filled syringe will be removed from storage at 2-8oC at least 30 minutes prior to administration to allow the contents to come to room temperature. The pre-filled syringe will be visually inspected for discolouration and particulates as per the product Summary of Product Characteristics.To facilitate maintenance of the blind, the pre-filled syringe (PFS) presentation will be used. The pen presentation will not be used. Receives: Drug: Adalimumab |
| Placebo | Placebo comparator | Sodium chloride 0.9% for injection will be used as a placebo to adalimumab. An equal volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection once fortnightly on four occasions. No dose adjustments are permitted. Prior to administration, the prepared placebo syringe will be visually inspected for discolouration and particulate matter prior to administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sickness score as measured using the sickness questionnaire
The sickness questionnaire is a 10-item instrument used to capture perceived sickness behaviour. It was developed to display sensitivity to an inflammatory challenge and have adequate psychometric properties.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Change in brain connectivity as measured by 7T MRI
Changes in dorsal attention network (DAN) - left inferior parietal lobule (LIPL) brain connectivity as measured by 7T MRI
Measured: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Secondary outcomes (21)
Changes in fatigue from Baseline to Visit 4 via BRAF Severity
Fatigue, measured by BRAF severity
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in fatigue from Baseline to Visit 4 via PROMIS Fatigue
Fatigue, measured by PROMIS-Fatigue.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in Hyperalgesia from Baseline to Visit 4 via ACR-FM Scale
Hyperalgesia, measured by the ACR-FM Scale (American College of Rheumatology Fibromyalgia Scale).
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via McGill Pain Questionnaire
Pain, measured by McGill Pain Questionnaire
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Michigan Body Map Regional Pain Intensity
Pain, measured by Michigan Body Map Regional Pain Intensity.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Finger Perception Task
Pain, measured by Finger Perception Task.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Neglect-like Symptoms Questionnaire.
Pain, measured by Neglect-like Symptoms Questionnaire.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Number Rating Scale - Pain
Pain, measured by Number Rating Scale - Pain.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in sleep disturbance from Baseline to Visit 4
Sleep disturbance, measured by PROMIS-Sleep related impairment.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via HADS
Mood, measured by HADS (Hospital Anxiety Depression Scale).
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via PROMIS-Depression
Mood, measured by PROMIS-Depression
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via PROMIS-Anxiety
Mood, measured by PROMIS-Anxiety.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in cognition from Baseline to Visit 4
Cognition, measured by Cognitive failures questionnaire.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in processing speed from Baseline to Visit 4
Processing Speed, measured by Symbol Digit Modalities Test.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in memory from Baseline to Visit 4
Memory, measured by Auditory Verbal Learning Test.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in verbal fluency from Baseline to Visit 4
Memory, measured by Auditory Verbal Learning Test.
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Change in brain network connectivity at Baseline and Visit 4
Change in brain network connectivity as measured by 7T Magnetic Resonance Imaging (MRI).
Measured: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Change in brain glutamate quantification at Baseline and Visit 4
Change in brain glutamate quantification as measured by 7T Magnetic Resonance Spectroscopy (MRS).
Measured: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via DAS28
Indices of of disease activity for Rheumatoid Arthritis as measured by DAS28 (Disease Activity Score-28).
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via CDAI
Indices of of disease activity for Rheumatoid Arthritis as measured by CDAI (Clinical Disease Activity Index).
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via SDAI
Indices of of disease activity for Rheumatoid Arthritis as measured by SDAI (Simple Disease Activity Index).
Measured: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start4 Nov 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised 1:1 to receive adalimumab or placebo. Upon exiting the study, those in the treatment arm will continue to receive adalimumab without delay and those in the placebo arm will begin adalimumab therapy under NHS standard of care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jonathan Cavanagh, MD, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090124
- Sponsor's protocol ID
- GN18MH540
- Acronym
- REALISE
- Status last verified
- Jan 2025
- First submitted
- 20 Jul 2021
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Medicine Studies of Brain and Peripheral Immune Mechanisms for Sickness Behaviours in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05090124
- Acronym / sponsor ID
- REALISE / GN18MH540
- Conditions
- Rheumatoid Arthritis
- Keywords
- Sickness Behaviour, Tumour Necrosis Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal studies. Data supporting the role of inflammatory molecules in sickness behaviours and other cognitive disorders are increasingly compelling. A putative mechanism linking inflammatory proteins to sickness behaviour is Tumour Necrosis Factor (TNF)-driven increases in extracellular glutamate leading to changes in neural function and brain network integrity and ultimately to sickness behaviour. Investigators hypothesise that TNF antagonism will effect changes in brain network connectivity and sickness behaviour score, that Rheumatoid Arthritis (RA) patients will show changes in brain network connectivity and glutamate quantification in the brain and that RA patients will show changes in monocyte infiltration into the brain that are correlated with changes in sickness behaviours. This is a randomised, placebo-controlled waiting list study. All patients will be eligible for anti-TNF treatment i.e. moderate to severe active disease as defined by Physician. Participants will be randomised to immediate (fast tracked) treatment or to treatment after 6-8 weeks (the routine waiting time). The latter group will receive placebo during the treatment phase.
Detailed description
The study will involve participants aged over 18 years with RA and are scheduled to start outpatient anti-TNF treatment (with Adalimumab) as part of standard clinical care, who meet the inclusion criteria and none of the specified exclusion criteria. All will give full informed consent. This is a single-blind, randomised placebo-controlled waiting list study and after screening and consent, eligible participants will be randomised (1:1) to receive either adalimumab or placebo.
The study comprises standard care screening for anti-TNF therapy (incorporated into the study to allow us to fast track screening), a total of 7 research visits and one remote visit via telephone. At Visit 1 (Day 0) and Visit 4 ((14 ± 2 days from Visit 3), participants will undergo 7T MRI and MRS Neuroimaging protocols that incorporate resting-state and task-based fMRI and glutamate MRS measures. At Visit 1A (1 - 7 days from Visit 1) and Visit 4A (1 - 7 days from Visit 4), participants will undergo an optional SPECT scanning protocol. This visit will involve a 160ml blood draw, from which monocytes will be isolated and radiolabelled before being reinjected prior to SPECT scanning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomised 1:1 to receive adalimumab or placebo. Upon exiting the study, those in the treatment arm will continue to receive adalimumab without delay and those in the placebo arm will begin adalimumab therapy under NHS standard of care.
| Arm | Type | Receives |
|---|---|---|
| anti-TNF treatment | Experimental | Drug: AdalimumabAdalimumab 40mg, will be administered as a subcutaneous injection once fortnightly on four occasions. No dose adjustments are permitted. The actual Adalimumab product selected at site will be dictated by what is used in standard care. The single-use, pre-filled syringe will be removed from storage at 2-8oC at least 30 minutes prior to administration to allow the contents to come to room temperature. The pre-filled syringe will be visually inspected for discolouration and particulates as per the product Summary of Product Characteristics.To facilitate maintenance of the blind, the pre-filled syringe (PFS) presentation will be used. The pen presentation will not be used. |
| Placebo | Placebo comparator | Drug: PlaceboSodium chloride 0.9% for injection will be used as a placebo to adalimumab. An equal volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection once fortnightly on four occasions. No dose adjustments are permitted. Prior to administration, the prepared placebo syringe will be visually inspected for discolouration and particulate matter prior to administration. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults ≥ 18 years < 75 years.
- Physician diagnosed moderate to severe RA.
- No previous biologic disease modifying antirheumatic drug therapy
- Usual care physician has confirmed the patient is eligible for anti-TNF treatment for active RA in line with the license for adalimumab (originator or biosimilar) and local practice subject to satisfactory completion of standard pre-biologic safety screening. Standard pre-biologic safety screening includes but not limited to exclusion of latent TB infection according to local protocol, chest X-ray, negative HIV screen, negative Hepatitis screen antibody, negative Hepatitis B surface antigen [Hep B sAg] and negative Hepatitis B anti-core antibody [Hep B cAb]
- Note: Participant consent to treatment with adalimumab will have been obtained by the usual care team as per standard practice at site and will be prior to any approach for this study.
Key exclusion criteria (16 listed)
- Inability to provide written informed consent.
- Severe physical impairment (e.g. blindness, deafness, paraplegia).
- Pregnant, planning pregnancy or breast feeding.
- Serious infection including sepsis, tuberculosis and opportunistic infections such as invasive fungal infections.
- Severe liver or renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humira, Amgevita, Imraldi, HyrimozAdalimumab 40mg, will be administered as a subcutaneous injection once fortnightly on four occasions. The actual Adalimumab product selected at site will be dictated by what is used in standard care. | Drug | anti-TNF treatment |
| PlaceboAlso: Sodium chloride 0.9% for injectionSodium chloride 0.9% for injection will be used as a placebo. An equal volume will be drawn up into a suitable sized syringe and labelled in accordance with standard practice at site. The dose will be administered as a subcutaneous injection once fortnightly on four occasions. | Drug | Placebo |
Primary outcome
Change in sickness score as measured using the sickness questionnaire
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
The sickness questionnaire is a 10-item instrument used to capture perceived sickness behaviour. It was developed to display sensitivity to an inflammatory challenge and have adequate psychometric properties.
Change in brain connectivity as measured by 7T MRI
Time frame: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Changes in dorsal attention network (DAN) - left inferior parietal lobule (LIPL) brain connectivity as measured by 7T MRI
21 secondary outcomes
Changes in fatigue from Baseline to Visit 4 via BRAF Severity
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in fatigue from Baseline to Visit 4 via PROMIS Fatigue
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in Hyperalgesia from Baseline to Visit 4 via ACR-FM Scale
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via McGill Pain Questionnaire
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Michigan Body Map Regional Pain Intensity
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Finger Perception Task
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Neglect-like Symptoms Questionnaire.
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in pain from Baseline to Visit 4 via Number Rating Scale - Pain
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in sleep disturbance from Baseline to Visit 4
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via HADS
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via PROMIS-Depression
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in mood from Baseline to Visit 4 via PROMIS-Anxiety
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in cognition from Baseline to Visit 4
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in processing speed from Baseline to Visit 4
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in memory from Baseline to Visit 4
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Changes in verbal fluency from Baseline to Visit 4
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Change in brain network connectivity at Baseline and Visit 4
Time frame: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Change in brain glutamate quantification at Baseline and Visit 4
Time frame: Visit 1 (Baseline, Day 0) and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via DAS28
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via CDAI
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Measures of RA disease activity from Baseline to Visit 4 via SDAI
Time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Cavanagh, MD, PhD principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adalimumab in people with Rheumatoid Arthritis, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sickness score as measured using the sickness questionnaire (time frame: Visit 1 (Baseline, Day 0), Visit 2 (14 ± 2 days from Visit 1 or Visit 1A), Visit 3 (14 ± 2 days from Visit 2), and Visit 4 (14 ± 2 days from Visit 3).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.