Rheumatoid ArthritisPhase 2NCT03239080
Effect of Denosumab in Erosion Healing in RA
A Phase 2 study testing Denosumab in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2017to 24 May 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- DAS28 ≤5.1
- without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT
Who cannot join
- RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
- treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
- pregnancy or premenopausal women planning pregnancy
- previous use of denosumab, zoledronic acid or teriparatide
- Hyperparathyroidism
- contraindications to denosumab
- Bisphosphonate, biologic DMARDs and the use of oral glucocorticoid >10 mg/day (prednisolone equivalent)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Denosumab, Placebo
- Keywords
- Rheumatoid Arthritis, HR-pQCT, erosion, denosumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
PlaceboOther
Subcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Active comparator | Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). Receives: Drug: Denosumab |
| Placebo | Placebo comparator | Subcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of > SDC in osteosclerosis at the margin of erosion.
Measured: 12 months
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of > SDC in osteosclerosis at the margin of erosion.
Measured: 24 months
Secondary outcomes (5)
Erosion progression
Changes in size of erosion (depth, width and volume) and marginal osteosclerosis (semi-quantitative and quantitative) using HR-pQCT
Measured: 12 and 24 month
Radiographic progression
Radiographic progression expressed by changes in van der Heijde-Sharp score on radiograph
Measured: 12 and 24 months
Change in various patient-reported outcomes
Changes in physical function (HAQ) will be measured
Measured: 12 and 24 month
Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ
Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ will be analysed
Measured: 24 month
Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT
Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT
Measured: 12 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start19 Jun 2017
- Primary completion24 May 2020
- Study completion24 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-Shan Tam, Chinese University of Hong Kong
- Investigators
- Lai Shan Tam, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239080
- Sponsor's protocol ID
- RA-RANKL-2017
- Status last verified
- Nov 2020
- First submitted
- 1 Aug 2017
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
So H, Cheng IT, Lau SL, Chow E, Lam T, Hung VW, Li EK, Griffith JF, Lee VW, Shi L, Huang J, Kwok KY, Yim CW, Li TK, Lo V, Lee J, Lee JJ, Qin L, Tam LS. Effects of RANKL inhibition on promoting healing of bone erosion in rheumatoid arthritis using HR-pQCT: a 2-year, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2021 Aug;80(8):981-988. doi: 10.1136/annrheumdis-2021-219846. Epub 2021 Apr 2.
PubMed 33811034
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT
- ClinicalTrials.gov ID
- NCT03239080
- Acronym / sponsor ID
- RA-RANKL-2017
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, HR-pQCT, erosion, denosumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 24 May 2020 (actual)
- First posted
- 3 Aug 2017 (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.
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
Detailed description
This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Active comparator | Drug: DenosumabSubcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old
- DAS28 ≤5.1
- without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT
Key exclusion criteria (7 listed)
- RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
- treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
- pregnancy or premenopausal women planning pregnancy
- previous use of denosumab, zoledronic acid or teriparatide
- Hyperparathyroidism
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 |
|---|---|---|
| DenosumabSubcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). | Drug | Denosumab |
| PlaceboSubcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months). | Other | Placebo |
Primary outcome
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
Time frame: 12 months
1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of > SDC in osteosclerosis at the margin of erosion.
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
Time frame: 24 months
1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of > SDC in osteosclerosis at the margin of erosion.
5 secondary outcomes
Erosion progression
Time frame: 12 and 24 month
Radiographic progression
Time frame: 12 and 24 months
Change in various patient-reported outcomes
Time frame: 12 and 24 month
Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ
Time frame: 24 month
Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT
Time frame: 12 and 24 month
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 24 Nov 2020.
- Derived from this study: PubMed 33811034So H, Cheng IT, Lau SL, Chow E, Lam T, Hung VW, Li EK, Griffith JF, Lee VW, Shi L, Huang J, Kwok KY, Yim CW, Li TK, Lo V, Lee J, Lee JJ, Qin L, Tam LS. Effects of RANKL inhibition on promoting healing of bone erosion in rheumatoid arthritis using HR-pQCT: a 2-year, randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2021 Aug;80(8):981-988. doi: 10.1136/annrheumdis-2021-219846. Epub 2021 Apr 2.
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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.
Lai Shan Tam, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
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 3 inclusion and 7 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4 (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03239080, which also lists 1 linked publication.
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 24 Nov 2020.