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Trial registered on ANZCTR


Registration number
ACTRN12620000827932
Ethics application status
Approved
Date submitted
13/05/2020
Date registered
18/08/2020
Date last updated
18/08/2020
Date data sharing statement initially provided
18/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Golimumab for rheumatoid arthritis
Scientific title
A phase 4, longitudinal, single-arm, open-label treatment study of subcutaneous golimumab effectiveness assessed by both speed of magnetic resonance imaging (MRI) changes in the hand/wrist and clinical response outcomes in patients with rheumatoid arthritis.
Secondary ID [1] 301255 0
ER-RA-MRI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 317432 0
Condition category
Condition code
Inflammatory and Immune System 315525 315525 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants on this trial will receive open-label golimumab 50mg subcutaneously every four weeks for a total of twelve weeks to assess the speed of golimumab response on MRI scans of the dominant hand/wrist and on other clinical outcome measures of rheumatoid arthritis. The participants will self-administer golimumab for the duration of the trial. There is no placebo or control arms. The participant will be asked about study drug compliance at each visit to ensure the participant is taking the study drug as prescribed.
Intervention code [1] 317578 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323792 0
A descriptive summary of the MRI findings using RAMRIS score in the chosen hand/wrist from screening (screening MRI to serve as the baseline MRI) to the MRI findings using RAMRIS score in the chosen hand/wrist at weeks 2, 6 and 12 in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [1] 323792 0
Weeks 2, 6, 12
Secondary outcome [1] 382906 0
The change in the number of swollen and tender joints using joint count assessment data from baseline to the number of swollen and tender joints at weeks 2, 6 and 12 will be described descriptively as a composite outcome in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [1] 382906 0
Weeks 2, 6, 12
Secondary outcome [2] 382907 0
The change in the number of swollen and tender joints to the MRI findings using the RAMRIS score at baseline (screening MRI to serve as the baseline MRI), week 2, week 6 and week 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [2] 382907 0
Week 2, 6, 12
Secondary outcome [3] 382908 0
The change in Arthritis disease activity assessed using the PRO PtGA responses from baseline to the PtGA responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [3] 382908 0
Weeks 2, 6, 12
Secondary outcome [4] 382909 0
The change in hand function using the PRO DASH responses from baseline to the DASH responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [4] 382909 0
Weeks 2, 6, 12
Secondary outcome [5] 382910 0
The change in disease activity using the PRO EQ-5D responses from baseline to the EQ-5D responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [5] 382910 0
Weeks 2, 6, 12
Secondary outcome [6] 382911 0
The change in disease activity using the PRO SF-36 responses from baseline to the SF-36 responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [6] 382911 0
Weeks 2, 6, 12
Secondary outcome [7] 382912 0
The change in disease activity using the PRO FACIT-F responses from baseline to the FACIT-F responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [7] 382912 0
Weeks 2, 6, 12
Secondary outcome [8] 382913 0
The change in the disease activity using the PhGA responses from baseline to the PhGA responses at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [8] 382913 0
Weeks 2, 6, 12
Secondary outcome [9] 382914 0
The change in disease activity using the DAS28-CRP result from baseline to the DAS28-CRP results at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [9] 382914 0
Weeks 2, 6, 12
Secondary outcome [10] 382915 0
The change in disease activity using the DAS28-ESR result from baseline to the DAS28-ESR results at weeks 2, 6 and 12 will be described descriptively in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.
Timepoint [10] 382915 0
Weeks 2, 6, 12

Eligibility
Key inclusion criteria
1 Male or female adult participants greater than or equal to 18years of age who can give informed consent, able to understand English and willing and able to complete the study activities.
2 Clinically defined active rheumatoid arthritis despite Methotrexate use (plus or minus other DMARDs), where active rheumatoid arthritis is defined as a DAS28-CRP equals 4.2 at screening.
3 Clinically active synovitis of the chosen hand or wrist on MRI at screening, as determined by the MRI reader.
4 The Methotrexate dose must be less than or equal to 25mg per week and the participant must also be on folic acid supplement according to local standard of care. The Methotrexate dose must have been stable for 3 months prior to baseline.
5 If the participant is on a DMARD in addition to Methotrexate at the time of screening (allowed but not required), the dose must have been stable for 3 months prior to baseline.
6 Non-steroidal anti-inflammatory drug (NSAID) medications are allowed but the participant is not required to be using these medications. If NSAIDs are being taken at the time of screening, the dose must have been stable for 10 days prior to baseline.
7 Prednisolone is allowed but the participant is not required to be using this medication. If prednisolone is being taken at the time of screening, the dose must be less than or equal to 10mg per day and the dose must have been stable for 2 weeks prior to baseline.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Negative (i.e. no signs of active clinical synovitis) MRI of the chosen hand/wrist at screen as determined by the central MRI reader.
2. Inability to have MRI due to either claustrophobia or other contraindications to MRI.
3. Contraindication to use of golimumab (such as active tuberculises or other severe infections; opportunistic infections; concurrent use of golimumab with anakinra or abatacept; hypersensitivity to the active substance or any of the excipients; risk of Hepatitis B reactivation [i.e. surface antigen positive]; congestive heart failure; demyelinating disorders).
4. No pregnant or breastfeeding; willing to use contraception
5. Previous biologic use of any class.
6. Previous use of a JAK inhibitor.
7. Active Tuberculosis (TB) as determined by local Quanti-FERON gold and local chest x-ray. If latent TB is diagnosed, the participant may be enrolled into the study providing treatment for latent TB according to local standard of care is initiated prior to the first dose of golimumab. If results are available from a chest x-ray and/or QuantiFERON gold within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility.
8. Recent infection requiring intravenous antibiotics in the previous three months.
9. Moderate to severe, uncontrolled, heart failure.
10. Positive Hepatitis B, Hepatitis C or HIV laboratory tests. If results are available from Hepatitis B, Hepatitis C or HIV laboratory tests within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility.
11. Malignancy in the previous 5 years. Adequately treated Squamous cell carcinoma, basal cell carcinoma and carcinoma in situ of the cervix are acceptable.
12. History of demyelinating disorders, including multiple sclerosis.
13. Live vaccines in the previous three months or plans to receive a live vaccine while on study (inactivated vaccines are acceptable).
14. Latex allergy or if the participant has a latex allergy, no caregiver who is able to give the golimumab injections.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
As an exploratory study, aspects will be considered in qualitative terms rather than by statistical analysis and findings will be descriptively described.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16662 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 30258 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 305703 0
Commercial sector/Industry
Name [1] 305703 0
Janssen-Cilag Pty Ltd
Address [1] 305703 0
1-5 Khartoum Road, Macquarie Park NSW 2113
Country [1] 305703 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Emeritus Research Pty Ltd
Address
Level 2, 1180 Toorak Road, Camberwell VIC 3124
Country
Australia
Secondary sponsor category [1] 306119 0
None
Name [1] 306119 0
Address [1] 306119 0
Country [1] 306119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305980 0
Bellberry Limited
Ethics committee address [1] 305980 0
123 Glen Osmond Road, Eastwood, SA, 5063.
Ethics committee country [1] 305980 0
Australia
Date submitted for ethics approval [1] 305980 0
16/06/2020
Approval date [1] 305980 0
22/07/2020
Ethics approval number [1] 305980 0

Summary
Brief summary
This study is designed to assess the rate of response to treatment (subcutaneous golimumab 50mg given four weekly) on MRI and other clinical RA measures in 12 participants diagnosed with active rheumatoid arthritis with inadequate response to Methotrexate. Study duration is 12 weeks. The aim is to assess at what timepoints specific MRI changes are seen with golimumab use; which aspects of rheumatoid involvement respond earliest; and if this precedes the timepoints when other clinical RA outcome measures change. Clinical response to treatment will involve assessing response to treatment on MRI of the participant’s most affected hand/wrist (as determined by Investigator assessment by examination at screening), as well as clinical outcome measures such as CRP, ESR and joint count assessments.
In addition, participant reported outcomes (PROs) will be completed to assess the overall disease activity levels as reported by the participant. The PROs chosen include the conventional PROs EQ-5D, SF-36, FACIT-F and PtGA as these are well-established PROs that have demonstrated validity and reliability in assessing disease state, as well as a specific upper limb function PRO, the DASH. Visit timepoints are baseline, week 2, week 6 and week 12. At the end of the study, the participant will return to their normal treating rheumatologist for ongoing care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102294 0
Prof Stephen Hall
Address 102294 0
Emeritus Research
Level 2, 1180 Toorak Road, Camberwell VIC 3124.
Country 102294 0
Australia
Phone 102294 0
+61 3 9509 6166
Fax 102294 0
Email 102294 0
stephenhall@emeritusresearch.com
Contact person for public queries
Name 102295 0
Ms Teresa Ringeri
Address 102295 0
Emeritus Research
Level 2, 1180 Toorak Road, Camberwell VIC 3124.
Country 102295 0
Australia
Phone 102295 0
+61 452 496 166
Fax 102295 0
Email 102295 0
teresaringeri@emeritusresearch.com
Contact person for scientific queries
Name 102296 0
Prof Stephen Hall
Address 102296 0
Emeritus Research
Level 2, 1180 Toorak Road, Camberwell VIC 3124.
Country 102296 0
Australia
Phone 102296 0
+61 3 9509 6166
Fax 102296 0
Email 102296 0
stephenhall@emeritusresearch.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A clinical trial summary will be completed, as will a Final Study Report that will detail results of the trial. A publication will also be considered with the study findings.
What supporting documents are/will be available?
Study protocol
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7931 0
Study protocol
Citation [1] 7931 0
Link [1] 7931 0
Email [1] 7931 0
teresaringeri@emeritusresearch.com
Other [1] 7931 0
Attachment [1] 7931 0
Type [2] 7932 0
Informed consent form
Citation [2] 7932 0
Link [2] 7932 0
Email [2] 7932 0
teresaringeri@emeritusresearch.com
Other [2] 7932 0
Attachment [2] 7932 0
Type [3] 7933 0
Clinical study report
Citation [3] 7933 0
Link [3] 7933 0
Email [3] 7933 0
teresaringeri@emeritusresearch.com
Other [3] 7933 0
Attachment [3] 7933 0
Type [4] 7934 0
Ethical approval
Citation [4] 7934 0
Link [4] 7934 0
Email [4] 7934 0
teresaringeri@emeritusresearch.com
Other [4] 7934 0
Attachment [4] 7934 0
Summary results
No Results