Knee OsteoarthritisPhase 2/3NCT02176460
Colchicine for Symptom and Inflammation in Knee Osteoarthritis
A Phase 2/3 study testing Colchicine in people with Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Uric acid may be involved in the activation of the innate immune response in osteoarthritis (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial for OA. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2013to Sep 2015
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic knee OA meeting American College of Rheumatology (ACR) criteria
- Radiographic criteria for knee OA with Kellgren-Lawrence (KL) stage of ≥ 2 in at least one knee
- Response positive to the question "do you have pain, aching or stiffness of the knee on most days of the past month
- Score of ≥ 40 out of 100 on a visual analogue scale (VAS) for pain
- Age ≥ 21 years or above
- Male and female subjects and all ethnicities included
- Patients to agree to avoid consuming grapefruit and grapefruit juice while using colchicine
- Ability to provide informed consent
Who cannot join
- Exposure to a corticosteroid (either parenteral or oral) within 3 months prior to the study enrolment
- Knee arthroscopic surgery within 6 months prior to the study enrolment
- Known history of avascular necrosis, inflammatory arthritis (e.g. Rheumatoid Arthritis), Paget's disease, joint infection, periarticular fracture, neuropathic arthropathy, Reiter's syndrome, or gout involving the knee
- Contraindication to arthrocentesis (warfarin use, bleeding disorder, skin rash or skin infection of signal knee)
- Knee joint replacement;
- History of podagra, active gout or treatment for gout
Show all 17Show fewer
- Pregnancy or lactation - women of childbearing potential will have serum pregnancy testing (ßHCG) at time of entry prior to any imaging studies (X-ray or MRI); female subjects of childbearing potential must agree to use some form of contraception during the 16 week trial and for 1 week after the end of the trial (over 6 half-life equivalents)
- Renal failure with serum creatinine > 150mmol/L (1.7 mg/dL);
- Hepatic impairment defined by serum alanine transaminase (ALT) above the upper limit of normal for the clinical laboratory performing the screening test
- Muscle impairment defined by elevated serum creatine phosphokinase (CPK) above the upper limit of normal for the clinical laboratory performing the screening test
- Personnel directly affiliated with this study or their immediate family members (defined as a spouse, parent, child or sibling, whether biological or legally adopted)
- Current enrolment in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study
- Inability to understand and cooperate with the investigators or to give valid consent;
- Contraindication for magnetic resonance imaging (MRI) - this is exclusion only for the subset of individuals selected for this imaging procedure;
- Anticipation of need for joint replacement within 4 months of the start of the intervention;
- Current treatment with drugs known to inhibit Cytochrome 450(3A4) isoforms and/or P-glycoprotein (P-gp) that increase the risk of colchicine-induced toxic effects (see: http://www.fda.gov/Drugs/Drug-safety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm).
- Inclusion can be considered after 14 day wash out of agents listed in the drug information sheet, but only if treatment in the near future with one of these agents is not anticipated. The clinical necessity for such treatments during the study will require immediate discontinuation of the study drug and conversion of the patient to standard care. However, the patient will remain on study and scheduled measurements taken. Analyses will be performed on an intention-to-treat basis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Colchicine for Symptom and Inflammation Modification in Knee Osteoarthritis
Uric acid may be involved in the activation of the innate immune response in osteoarthritis (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial for OA. Our goal therefore is to assess colchicine, an existing commercially available agent for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. This trial will potentially provide data to support a new treatment option for knee OA.
Read the detailed description
In a knee OA cohort with no clinical evidence or self-report of gout, The investigators recently found a significant correlation of synovial fluid uric acid with radiographic and scintigraphic measures of OA severity [1]. The investigators also observed strong correlations of OA severity (radiographically and scintigraphically determined) and synovial fluid uric acid with synovial fluid Interleukin (IL)-18 and IL-1β; these two cytokines are classically produced during gout attacks by innate immune system activation mediated by uric acid crystal-induced inflammasome assembly in macrophages. These results strongly support the involvement of uric acid and the innate immune system in OA pathology and progression. Whereas in gout flares, uric acid in a crystal form is what triggers the innate immune response, we suspect that in OA, uric acid in a microcrystalline or particulate form is the pathogenic agent -- able to trigger an innate immune response; this leads to release of inflammatory cytokines like IL-18, IL-1β and subsequently tumor necrosis factor - α which perpetuates further cartilage degradation. This new conception of the pathogenesis of OA has very important treatment implications; it suggests that existing therapies for gout may be of benefit in OA. Colchicine may be an effective treatment for OA due to its capacity in suppressing the innate immune response at various levels. At micromolar concentrations colchicine suppresses activation of the crystal-induced (NACHT), (LRR) and (PYD) domains containing protein-3 (NALP3) inflammasome; IL-1β processing and release; and L-selectin expression on neutrophils [2]. At nanomolar concentrations colchicine has blocks the release of a crystal-derived chemotactic factor from neutrophil lysosomes; it blocks neutrophil adhesion to endothelium by modulating the distribution of adhesion molecules on the endothelial cells; and it inhibits urate crystal-induced production of superoxide anions from neutrophils and macrophages. The pain and symptom relieving effects of colchicine for knee OA have been demonstrated in three small but well-performed human randomized controlled trials [3-5]; however, the mechanism of action of colchicine in OA has never been evaluated.
The investigators therefore propose a RCT of colchicine to examine the effects on signs and symptoms of knee OA and to evaluate the mechanism of action through analysis of synovial fluid and systemic biomarker profiles.
Hypothesis: The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid serum and urine inflammatory and biochemical joint degradation biomarkers.
Aim 1. To determine whether daily oral colchicine at standard clinical doses (0.5 mg two times daily), compared to placebo, can decrease the pain of symptomatic OA knee and improve function when used as adjunctive daily therapy in addition to background therapy with the patient's current stable analgesic regimen.
Aim 2. To evaluate the mechanism of action of colchicine for reducing knee OA signs and symptoms through analyses of synovial fluid, serum, and urine biomarker profiles - these will interrogate and characterize the state of activation of joint metabolism (joint degradation and synthesis markers), inflammatory mediators, the innate immune system and the NALP3 inflammasome components specifically both before (at baseline) and after 16 weeks therapy (at study end) with oral colchicine versus placebo treatment.
This pilot phase II study uses a double-blinded, randomized, placebo, controlled design. Patients with symptomatic and radiographic knee OA (n=120) will be randomized to colchicine (SIN 12490P) 0.5 mg bid (n=60) or placebo (n=60) daily for 16 weeks. Patients will be permitted to remain on their baseline adjunctive therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) without changes for the duration of the study. They will also be allowed the use of paracetamol not more than 2 g/day as rescue analgesia and pill counting at the end of the study will be conducted to determine the amount of rescue medicine utilized over the course of the 16-week study.
- Conditions
- Knee Osteoarthritis
- Being tested
- Colchicine, Placebo
- Keywords
- Knee Osteoarthritis, Double-blind, placebo-controlled, randomized, colchicine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called generic colchicine tablets (SIN 12490P)
0.5mg twice daily for 16 weeks
PlaceboDrug
Also called placebo tablet
1 tablet twice daily
| Study group | Role | What they receive |
|---|---|---|
| colchicine | Experimental | 0.5mg twice daily for 16 weeks Receives: Drug: Colchicine |
| placebo tablet | Placebo comparator | 1 tablet twice daily for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% improvement in total Western Ontario and McMaster Universities Arthritis Index (WOMAC) of the signal knee.
The primary end point will be 30% improvement in total Western Ontario and McMaster Universities Arthritis Index (WOMAC) of the signal knee.
Measured: baseline and week 16
Secondary outcomes (8)
change in WOMAC pain score and physical function score
Measured: baseline and week 16
change in Health Assessment Questionnaire (HAQ)
Measured: baseline and week 16
change in quality of life
Medical Outcome Short form 36
Measured: baseline and week 16
quantify of rescue medication used
paracetamol
Measured: baseline and week 16
Change in Synovitis and cartilage morphology on Magnetic Resonance Imaging
In a subgroup of participants (10 participants in interventional arm and 10 participants in placebo arm)
Measured: baseline and week 16
change in synovial fluid Interleukin-18, Interleukin-1β, or tumor necrosis factor -α
Measured: baseline and week 16
specific adverse event
signs or symptoms of colchicine toxicity such as muscle weakness or pain, numbness or tingling in the fingers or toes, diarrhoea, vomiting, elevation of muscle enzyme
Measured: from baseline to week 16
OMERACT-ORSI response criteria
Outcome Measure in Rheumatology (OMERACT-) - Osteoarthritis Research Society International (ORSI-) response criteria
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Ying Y Leung, MBChB, Principal investigator, Singapore General HospitalVirginia Kraus, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176460
- Sponsor's protocol ID
- COL-01
- Status last verified
- Apr 2016
- First submitted
- 26 Jun 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Leung YY, Haaland B, Huebner JL, Wong SBS, Tjai M, Wang C, Chowbay B, Thumboo J, Chakraborty B, Tan MH, Kraus VB. Colchicine lack of effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):631-640. doi: 10.1016/j.joca.2018.01.026. Epub 2018 Feb 7.
PubMed 29426008Leung YY, Thumboo J, Wong BS, Haaland B, Chowbay B, Chakraborty B, Tan MH, Kraus VB. Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:200. doi: 10.1186/s13063-015-0726-x.
PubMed 25925674
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Colchicine for Symptom and Inflammation Modification in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02176460
- Acronym / sponsor ID
- COL-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Double-blind, placebo-controlled, randomized, colchicine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke University, Duke-NUS Graduate Medical School
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
Uric acid may be involved in the activation of the innate immune response in osteoarthritis (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial for OA. Our goal therefore is to assess colchicine, an existing commercially available agent for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. This trial will potentially provide data to support a new treatment option for knee OA.
Detailed description
In a knee OA cohort with no clinical evidence or self-report of gout, The investigators recently found a significant correlation of synovial fluid uric acid with radiographic and scintigraphic measures of OA severity [1]. The investigators also observed strong correlations of OA severity (radiographically and scintigraphically determined) and synovial fluid uric acid with synovial fluid Interleukin (IL)-18 and IL-1β; these two cytokines are classically produced during gout attacks by innate immune system activation mediated by uric acid crystal-induced inflammasome assembly in macrophages. These results strongly support the involvement of uric acid and the innate immune system in OA pathology and progression. Whereas in gout flares, uric acid in a crystal form is what triggers the innate immune response, we suspect that in OA, uric acid in a microcrystalline or particulate form is the pathogenic agent -- able to trigger an innate immune response; this leads to release of inflammatory cytokines like IL-18, IL-1β and subsequently tumor necrosis factor - α which perpetuates further cartilage degradation. This new conception of the pathogenesis of OA has very important treatment implications; it suggests that existing therapies for gout may be of benefit in OA. Colchicine may be an effective treatment for OA due to its capacity in suppressing the innate immune response at various levels. At micromolar concentrations colchicine suppresses activation of the crystal-induced (NACHT), (LRR) and (PYD) domains containing protein-3 (NALP3) inflammasome; IL-1β processing and release; and L-selectin expression on neutrophils [2]. At nanomolar concentrations colchicine has blocks the release of a crystal-derived chemotactic factor from neutrophil lysosomes; it blocks neutrophil adhesion to endothelium by modulating the distribution of adhesion molecules on the endothelial cells; and it inhibits urate crystal-induced production of superoxide anions from neutrophils and macrophages. The pain and symptom relieving effects of colchicine for knee OA have been demonstrated in three small but well-performed human randomized controlled trials [3-5]; however, the mechanism of action of colchicine in OA has never been evaluated.
The investigators therefore propose a RCT of colchicine to examine the effects on signs and symptoms of knee OA and to evaluate the mechanism of action through analysis of synovial fluid and systemic biomarker profiles.
Hypothesis: The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid serum and urine inflammatory and biochemical joint degradation biomarkers.
Aim 1. To determine whether daily oral colchicine at standard clinical doses (0.5 mg two times daily), compared to placebo, can decrease the pain of symptomatic OA knee and improve function when used as adjunctive daily therapy in addition to background therapy with the patient's current stable analgesic regimen.
Aim 2. To evaluate the mechanism of action of colchicine for reducing knee OA signs and symptoms through analyses of synovial fluid, serum, and urine biomarker profiles - these will interrogate and characterize the state of activation of joint metabolism (joint degradation and synthesis markers), inflammatory mediators, the innate immune system and the NALP3 inflammasome components specifically both before (at baseline) and after 16 weeks therapy (at study end) with oral colchicine versus placebo treatment.
This pilot phase II study uses a double-blinded, randomized, placebo, controlled design. Patients with symptomatic and radiographic knee OA (n=120) will be randomized to colchicine (SIN 12490P) 0.5 mg bid (n=60) or placebo (n=60) daily for 16 weeks. Patients will be permitted to remain on their baseline adjunctive therapy, including non-steroidal anti-inflammatory drugs (NSAIDs) without changes for the duration of the study. They will also be allowed the use of paracetamol not more than 2 g/day as rescue analgesia and pill counting at the end of the study will be conducted to determine the amount of rescue medicine utilized over the course of the 16-week study.
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 |
|---|---|---|
| colchicine | Experimental | Drug: Colchicine0.5mg twice daily for 16 weeks |
| placebo tablet | Placebo comparator | Drug: Placebo1 tablet twice daily for 16 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic knee OA meeting American College of Rheumatology (ACR) criteria
- Radiographic criteria for knee OA with Kellgren-Lawrence (KL) stage of ≥ 2 in at least one knee
- Response positive to the question "do you have pain, aching or stiffness of the knee on most days of the past month
- Score of ≥ 40 out of 100 on a visual analogue scale (VAS) for pain
- Age ≥ 21 years or above
Key exclusion criteria (17 listed)
- Exposure to a corticosteroid (either parenteral or oral) within 3 months prior to the study enrolment
- Knee arthroscopic surgery within 6 months prior to the study enrolment
- Known history of avascular necrosis, inflammatory arthritis (e.g. Rheumatoid Arthritis), Paget's disease, joint infection, periarticular fracture, neuropathic arthropathy, Reiter's syndrome, or gout involving the knee
- Contraindication to arthrocentesis (warfarin use, bleeding disorder, skin rash or skin infection of signal knee)
- Knee joint replacement;
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 |
|---|---|---|
| ColchicineAlso: generic colchicine tablets (SIN 12490P)0.5mg twice daily for 16 weeks | Drug | colchicine |
| PlaceboAlso: placebo tablet1 tablet twice daily | Drug | placebo tablet |
Primary outcome
30% improvement in total Western Ontario and McMaster Universities Arthritis Index (WOMAC) of the signal knee.
Time frame: baseline and week 16
The primary end point will be 30% improvement in total Western Ontario and McMaster Universities Arthritis Index (WOMAC) of the signal knee.
8 secondary outcomes
change in WOMAC pain score and physical function score
Time frame: baseline and week 16
change in Health Assessment Questionnaire (HAQ)
Time frame: baseline and week 16
change in quality of life
Time frame: baseline and week 16
quantify of rescue medication used
Time frame: baseline and week 16
Change in Synovitis and cartilage morphology on Magnetic Resonance Imaging
Time frame: baseline and week 16
change in synovial fluid Interleukin-18, Interleukin-1β, or tumor necrosis factor -α
Time frame: baseline and week 16
specific adverse event
Time frame: from baseline to week 16
OMERACT-ORSI response criteria
Time frame: week 16
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 15 Apr 2016.
- Derived from this study: PubMed 29426008Leung YY, Haaland B, Huebner JL, Wong SBS, Tjai M, Wang C, Chowbay B, Thumboo J, Chakraborty B, Tan MH, Kraus VB. Colchicine lack of effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): a randomized controlled trial. Osteoarthritis Cartilage. 2018 May;26(5):631-640. doi: 10.1016/j.joca.2018.01.026. Epub 2018 Feb 7.
- Derived from this study: PubMed 25925674Leung YY, Thumboo J, Wong BS, Haaland B, Chowbay B, Chakraborty B, Tan MH, Kraus VB. Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:200. doi: 10.1186/s13063-015-0726-x.
- Individual participant dataSharing planned: Undecided
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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.
Ying Y Leung, MBChB principal investigator
Singapore General Hospital
Virginia Kraus, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine in people with Knee Osteoarthritis, run by Singapore General Hospital at 1 site in Singapore.
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 8 inclusion and 17 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 15 Apr 2016. 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 Singapore. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
30% improvement in total Western Ontario and McMaster Universities Arthritis Index (WOMAC) of the signal knee. (time frame: baseline and week 16). 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 NCT02176460, which also lists 2 linked publications.
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 15 Apr 2016.