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Trial registered on ANZCTR


Registration number
ACTRN12612000791831
Ethics application status
Approved
Date submitted
24/07/2012
Date registered
25/07/2012
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Humira for active hand osteoarthritis (HUMOR Trial)
Scientific title
Effect of Adalimumab (Humira) on hand pain in erosive hand osteoarthritis
Secondary ID [1] 280875 0
Nil
Universal Trial Number (UTN)
Trial acronym
HUMOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hand Osteoarthritis 286946 0
Condition category
Condition code
Musculoskeletal 287282 287282 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adalimumab 40 mg subcutaneous injection eow (every other week) for 3 months, crossover with 60 day washout.
Intervention code [1] 285310 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline injection) eow (every other week) for 3 months
Control group
Placebo

Outcomes
Primary outcome [1] 287561 0
Adalimumab 40 mg eow (every other week) will be superior to placebo for pain (measured by 100mm visual analogue scale (VAS)) at 3 months in osteoarthritis of the hand with prevalent bone marrow lesions and/or synovitis.
Timepoint [1] 287561 0
3 months
Secondary outcome [1] 298396 0
Pain VAS at one month and two months
Timepoint [1] 298396 0
1 month, 2 months
Secondary outcome [2] 298397 0
AUSCAN Hand Osteoarthritis Index VA3.1 total score at one, two and three months
Timepoint [2] 298397 0
1 month, 2 months, 3 months
Secondary outcome [3] 298398 0
Bone Marrow Lesion (BML) size at 3 months assessed by MRI
Timepoint [3] 298398 0
3 months
Secondary outcome [4] 298399 0
Synovitis at 3 months assessed by MRI
Timepoint [4] 298399 0
3 months
Secondary outcome [5] 298400 0
Safety assessed by monitoring and reporting any adverse events. Adverse events include any changes in the health of a participant and will be self-reported.
Participants will be asked to report any adverse events at each monthly clinic visit. Participants will also be able to report events between clinic visits by telephoning the coordinator. Adverse events may include, for example, a reaction at the injection site, attendance at a hospital emergency department, hospitalisation. All adverse events will be reported to the Prinicpal Investigator at each site who will determine the relationship (or otherwise) to Adalimumab.
Timepoint [5] 298400 0
At baseline, 1 month, 2 months, 3 months

Eligibility
Key inclusion criteria
Hand OA based on physician diagnosis and ACR criteria.
Hand pain >50 on 100mm VAS.
Morning stiffness >30 minutes.
Subject is judged to be in good general health as determined by the Prinicpal Investigator based upon results of medical history, physical examination, laboratory profile and chest X-ray (CXR).
Subject has negative QuantiFERON-TB Gold test and negative CXR (PA and lateral view).
Subjects must be able and willing to provide written informed consent and to comply with the requirements of the study.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will not be eligable for study participation if he/she meets any of the following criteria:
Subject has been treated with any investigational drug of a chemical or biologic nature with a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to baseline visit.
Any infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to baseline visit or oral anti-infectives within 14 days prior to baseline visit.
Known hypersensitivity to adalimumab or its excipients.
History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
History of invasive infection (e.g., listeriosis and histoplasmosis), human immunodeficiency syndrome (HIV), or chronic or active Hepatitis C.
Subjects with an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study.
Hepatitis B: HBs Ag positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBs ab positive subjects.
Chronic recurring infections or active TB.
History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
Subject received any live vaccine within 3 months prior to study drug administration.
Subject has a history of clinically significant hematologic (e.g., severe anaemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
History of clinically significant drug or alcohol abuse in the last 12 months.
Clinically significant abnormal screening laboratory results as evaluated by the investigator.
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment of subject by allocation to next random number. Random number generation to allocate drug or placebo performed by researcher not involved in this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
TAS

Funding & Sponsors
Funding source category [1] 285665 0
Commercial sector/Industry
Name [1] 285665 0
Abbott Australasia Pty Ltd
Address [1] 285665 0
Locked Bag 5106
Botany
NSW 1455
Country [1] 285665 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Menzies Research Institute Tasmania
University of Tasmania
Private Bag 23
Hobart
Tasmania 7001
Country
Australia
Secondary sponsor category [1] 284498 0
None
Name [1] 284498 0
Address [1] 284498 0
Country [1] 284498 0
Other collaborator category [1] 276953 0
Individual
Name [1] 276953 0
Dr Paul Bird
Address [1] 276953 0
Optimus Research
95 Kareena Rd
MIRANDA
NSW 2228
Country [1] 276953 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287657 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 287657 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart
Tasmania 7001
Ethics committee country [1] 287657 0
Australia
Date submitted for ethics approval [1] 287657 0
10/10/2011
Approval date [1] 287657 0
28/05/2012
Ethics approval number [1] 287657 0
H12149

Summary
Brief summary
This study aims to determine the efficacy of Adalimumab for active hand osteoarthritis. Primary hypothesis is Adalimumab will be superior to placebo for pain at 3 months in osteoarthritis of the hand. The design is a randomised, double blind, placebo controlled, crossover trial. Subjects will be randomised to Adalimumab/placebo followed by a 60 day washout and then the converse Adalimumab/placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34459 0
Prof Graeme Jones
Address 34459 0
Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
HOBART TAS 7001
Country 34459 0
Australia
Phone 34459 0
+61 3 6226 7705
Fax 34459 0
Email 34459 0
Graeme.Jones@utas.edu.au
Contact person for public queries
Name 17706 0
Prof Professor Graeme Jones
Address 17706 0
Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
HOBART TAS 7001
Country 17706 0
Australia
Phone 17706 0
+61 (0)3 6226 7705
Fax 17706 0
+61 (0)3 6226 7764
Email 17706 0
g.jones@utas.edu.au
Contact person for scientific queries
Name 8634 0
Prof Professor Graeme Jones
Address 8634 0
Menzies Institute for Medical Research
University of Tasmania
Private Bag 23
HOBART TAS 7001
Country 8634 0
Australia
Phone 8634 0
+61 (0)3 6226 7705
Fax 8634 0
+61 (0)3 6226 7764
Email 8634 0
g.jones@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 348 0
Accepted 20 Feb 2018
https://www.ncbi.nlm.nih.gov/pubmed/29499287
Attachments [1] 348 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary