Rheumatoid ArthritisPhase 2NCT01264211
Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA)
A Phase 2 study testing Diacerein in people with Rheumatoid Arthritis, run by TRB Chemedica at 2 sites in Thailand.
Trial summary
To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Diacerein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesThailand
- Study dates
- Oct 2010to Apr 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 65 years;
- Active RA of ≥ 3 months duration but < 2 years, diagnosed according to the American College of Rheumatology (ACR) 1987 revised criteria for RA;
- RA global functional status class I-III;
- Treatment on an outpatient basis;
- Treatment with MTX for a minimum of 12 weeks, with stable weekly dose (10-20 mg) for at least 4 weeks before randomisation;
- Insufficient response to treatment with MTX, with disease activity score DAS28 > 4.0 at the time of screening and randomisation; the DAS28 must not change significantly from screening to baseline visit (change < 0.6);
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- Tender joint count (TJC) ≥ 6 (68 joint count) and swollen joint count (SJC) ≥ 6 (66 joint count) at screening and randomisation;
- Screening ESR ≥ 28 mm/h;
- Evidence of adequate contraceptive methods in women of childbearing potential. Female patients of childbearing potential are those who are not surgically sterile or post-menopausal. Adequate contraceptive methods are hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the entire duration of the study;
- Agreement not to drink alcohol for the duration of the study;
- Ability and agreement to comply with the requirements of the study protocol;
- Having given written informed consent to participate in the study.
Who cannot join
- History of active inflammatory arthritis other than RA;
- Any uncontrolled medical condition such as diabetes mellitus, asthma, cardiopulmonary disease, congestive heart failure, neurological disease, etc.;
- Alcohol abuse, defined as the consumption of more than one glass of beer or wine in a day;
- Moderate or severe liver disease (cirrhosis, hepatitis, liver insufficiency);
- Blood anomalies (significant cytopenia);
- History of, or currently active primary or secondary immunodeficiency;
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- Chronic hepatitis B (HBsAg positive or HBcAb positive with HBV DNA load ≥ 400 copies/ml) or hepatitis C (anti-HCV positive);
- Current known active, or history of, recurrent bacterial, viral, fungal, mycobacterial or other infections, or any infection requiring hospitalisation or treatment with i.v. antibiotics within 4 weeks prior to randomisation or oral antibiotics within 2 weeks prior to randomisation;
- Treatment with biologic DMARDs such as TNF antagonists, IL 1 receptor antagonists, IL 6 receptor antagonists, CTLA4Ig within 12 weeks prior to randomisation, and rituximab within 24 weeks prior to randomisation;
- Treatment with non-biologic DMARDs such as chloroquine, hydroxychloroquine, penicillamine, sulfasalazine within 4 weeks prior to randomisation, leflunomide, parenteral gold, oral gold within 8 weeks prior to randomisation, azathioprine and ciclosporin within 12 weeks prior to randomisation;
- Treatment with intra-articular injection of a depocorticosteroid within 8 weeks prior to randomisation;
- Treatment with NSAID or oral corticosteroids, unless the patient has been on a stable dose for at least 4 weeks before randomisation (maximal allowed daily dose of oral corticosteroid equivalent to prednisone 10 mg);
- Physical therapy and alternative therapies, unless the patient has received them regularly for at least 4 weeks before randomisation;
- Initiation of chronic treatment with antihistaminics, antidepressants or tranquilisers, within less than 12 weeks before randomisation.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of medicine, Chiangmai University
Chiang Mai, Chiangmai, 50002
Juree Rawdmanee
Sukhumvit, Bangkok, 10110
About this study
Official title: A 6-month Pilot Randomised Double-blind Placebo-controlled Multicentre, Phase 2 Study
To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.
To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral MTX therapy in those patients for up to 24 weeks
To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped (carry-over effect)
- Conditions
- Rheumatoid Arthritis
- Being tested
- Diacerein, Placebo
- Keywords
- Efficacy of Diacerein, Safety of Diacerein, Carry-over effect of Diacerein
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacereinDrug
Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks
PlaceboDrug
Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Diacerein | Experimental | Not described Receives: Drug: Diacerein |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ACR20 response criteria
Measured: 24 weeks
Secondary outcomes (1)
Percentage of patients achieving a moderate response according to EULAR response criteria (changes in DAS28 score)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionApr 2014
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.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264211
- Sponsor's protocol ID
- DAR-THA-05-01
- Status last verified
- Nov 2015
- First submitted
- 28 Jun 2010
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Louthrenoo W, Nilganuwong S, Nanagara R, Siripaitoon B, Collaud Basset S. Diacerein for the treatment of rheumatoid arthritis in patients with inadequate response to methotrexate: a pilot randomized, double-blind, placebo-controlled add-on trial. Clin Rheumatol. 2019 Sep;38(9):2461-2471. doi: 10.1007/s10067-019-04587-1. Epub 2019 May 19.
PubMed 31104217
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Pilot Randomised Double-blind Placebo-controlled Multicentre, Phase 2 Study
- ClinicalTrials.gov ID
- NCT01264211
- Acronym / sponsor ID
- DAR-THA-05-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Efficacy of Diacerein, Safety of Diacerein, Carry-over effect of Diacerein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TRB ChemedicaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Dec 2010 (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.
To evaluate the efficacy of Diacerein 100 mg daily versus placebo in reducing rheumatoid arthritis symptoms, when added to stable oral MTX therapy in patients with active early RA.
To evaluate the safety of Diacerein 100 mg daily when administrated in combination with oral MTX therapy in those patients for up to 24 weeks
To investigate a potential persistent effect, 4 weeks after Diacerein treatment is stopped (carry-over effect)
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 |
|---|---|---|
| Diacerein | Experimental | Drug: Diacerein |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female aged between 18 and 65 years;
- Active RA of ≥ 3 months duration but < 2 years, diagnosed according to the American College of Rheumatology (ACR) 1987 revised criteria for RA;
- RA global functional status class I-III;
- Treatment on an outpatient basis;
- Treatment with MTX for a minimum of 12 weeks, with stable weekly dose (10-20 mg) for at least 4 weeks before randomisation;
Key exclusion criteria (14 listed)
- History of active inflammatory arthritis other than RA;
- Any uncontrolled medical condition such as diabetes mellitus, asthma, cardiopulmonary disease, congestive heart failure, neurological disease, etc.;
- Alcohol abuse, defined as the consumption of more than one glass of beer or wine in a day;
- Moderate or severe liver disease (cirrhosis, hepatitis, liver insufficiency);
- Blood anomalies (significant cytopenia);
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 |
|---|---|---|
| DiacereinWeek 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks | Drug | Diacerein |
| PlaceboWeek 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks | Drug | Placebo |
Primary outcome
Percentage of patients with ACR20 response criteria
Time frame: 24 weeks
1 secondary outcome
Percentage of patients achieving a moderate response according to EULAR response criteria (changes in DAS28 score)
Time frame: 24 weeks
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 5 Nov 2015.
- Derived from this study: PubMed 31104217Louthrenoo W, Nilganuwong S, Nanagara R, Siripaitoon B, Collaud Basset S. Diacerein for the treatment of rheumatoid arthritis in patients with inadequate response to methotrexate: a pilot randomized, double-blind, placebo-controlled add-on trial. Clin Rheumatol. 2019 Sep;38(9):2461-2471. doi: 10.1007/s10067-019-04587-1. Epub 2019 May 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diacerein in people with Rheumatoid Arthritis, run by TRB Chemedica at 2 sites in Thailand.
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 12 inclusion and 14 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 5 Nov 2015. 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 Thailand. 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?
Percentage of patients with ACR20 response criteria (time frame: 24 weeks). 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 NCT01264211, 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 5 Nov 2015.