Rheumatoid ArthritisPhase 2TERRANCT01430507
A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
A Phase 2 study testing Revamilast in people with Rheumatoid Arthritis, run by Glenmark Pharmaceuticals Ltd. India at 36 sites in 5 countries.
Trial summary
Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that causes progressive damage to joints of the body, affecting the functional capacity. Effective management of patients with RA requires a multidisciplinary approach. 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?
- Revamilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 36 sitesin 5 countries
- Study dates
- Sep 2011to Dec 2012
- 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 ≥18 to ≤ 65 years of age
- Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR)
- Active RA defined as patients with:
- 6 swollen joint counts
- 6 tender/painful joint counts, and
- At least two of the three following criteria:
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- Rheumatoid Factor positive or Anti CCP positive
- CRP ≥1.2 times upper limit of normal reference range or ESR >28 mm/hr
- Morning stiffness lasting >45 min for at least last4 weeks
- DAS-28 CRP values ≥ 4.5 at screening (visit 1)
- Patients must have been on stable (15 mg to 25 mg) or maximum tolerated dose of MTX for at least 12 weeks prior to screening
- The patient's written informed consent to participate in the study
- Female participants must have a negative serum pregnancy test at screening visit.
- Males must agree to use barrier while on study medication and for 90 days after taking the last dose of study medication
- Must meet the following laboratory criteria:
- Hemoglobin ≥ 9 g/dL
- White blood cell (WBC) count; ≥3.0 X 109/L
- Platelet count ≥ 100,000 /L (100 X 109/L)
- Serum creatinine <1.5 mg/dL (or 133mol/L)
- Total bilirubin <2.0 mg/dL
- AST \& ALT<1.5 times upper limit of normal
Who cannot join
- Diagnosis of RA prior to 16 years of age (Juvenile RA)
- Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA
- Patients with any other autoimmune rheumatic disorders with the exception of Sjogren's syndrome.
- Patients with first degree relative with immune deficiency
- History of infection with human immunodeficiency virus and/or active hepatitis B or C
- Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients
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- Patients with a history of drug or alcohol abuse or chronic smoking
- Uncontrolled diabetes mellitus
- Concurrent diseases that might interfere with the conduct of the study,
- ECG abnormalities judged by the investigator to be clinically significant
- History of using any other test drug, one month before the beginning of this trial
- Women who are pregnant or breast-feeding or on hormonal therapy
- Patients who in the Investigator's opinion might not be suitable for the study.
- Patients with a life expectancy of less than 1 year
Trial locations and contacts
36 sites in 5 countries.
36 sites in 5 countries
India16 sites
Rathi Orthopaedic & Research Center
Ahmedabad, Gujarat
Shalby Hospitals
Ahmedabad, Gujarat
Chanre Rheumatology and Immunology centre and Research
Bangalore, Karnataka
M S Ramaiah Medical College and Hospital
Bangalore, Karnataka
Chennai Meenakshi Multispeciality Hospital Limited
Chennai, Tamil Nadu
Advance Rheumatology Clinic
Hyderabad, Andhra Pradesh
Mahavir Hospital and Research Center
Hyderabad, Andhra Pradesh
Sri Deepti Rheumatology Center
Hyderabad, Andhra Pradesh
Institute of Post Graduate Medical Education & Research (IPGMER)
Kolkata, West Bengal, 700020
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh
Kennisha Rheumatology Care & Diagnostics
Mumbai, Maharashtra
Sushrut Hospital Research Centre and PG Institute of Orthopaedics
Nagpur, Maharashtra
Vidarbha Arthritis & Superspeciality Clinic
Nagpur, Maharashtra
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh
Centre for Knee & Hip Surgery
Vadodara, Gujarat
Philippines7 sites
Internal Medicine and Rheumatology, Chong Hua Hospital
Cebu, Cebu
Brokenshire Memorial Hospital
Davao City, Davao Region
Department of Medicine, Davao Doctor's Hospital
Davao City, Davao Region
University of Perpetual Help Dalta Medical Center
Las Piñas, National Capital Region
Manila Doctors Hospital
Manila, National Capital Region
University of Santo Tomas Hospital
Manila, National Capital Region
St. Luke's Medical Center
Quezon City, National Capital Region
Poland7 sites
Oddział Kliniczny Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
Chełm Śląski, Silesian Voivodeship
Specjalistyczna Praktyka Lekarska Joanna Badowska
Częstochowa, Silesian Voivodeship
NZOZ Reumed
Lublin, Lublin Voivodeship
Osrodek Badan Klinicznych Prof. Dr hab. med.
Lublin, Lublin Voivodeship
Niepubliczny Zaklad Opieki Zdrowotnej Medica Pro Familia Sp. z o.o.
Warszawa, Lublin Voivodeship, 01-868
Wojewodzki Zespol Specjalistycznej Opieki Zdrowotnej
Wroclaw, Silesian Voivodeship, 50-403
Sri Lanka4 sites
Colombo South Teaching Hospital
Colombo, Colombo
National Hospital of Sri Lnka
Colombo, Colombo
Nawaloka Hospitals PLC
Colombo, Colombo
Teaching Hospital Karapitiya
Galle, Colombo
United Kingdom2 sites
The Leeds Teaching Hosptial NHS Trust, Chapel Allerton Hospital
Leeds, Yorkshire
Queen's Hospital
Romford, Essex
About this study
Official title: A Phase IIb, 12 Week Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Efficacy, Safety and Tolerability of Revamilast in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that causes progressive damage to joints of the body, affecting the functional capacity. Effective management of patients with RA requires a multidisciplinary approach. Despite the various combinations, there is a significant population of RA patients who are not responding to these combinations or showing inadequate response to methotrexate alone. Hence, there is a need for a unique combination of drugs targeting different pathological process to yield the best results in those patients where prognosis is poor. Combination of revamilast with first line therapy like methotrexate could provide better treatment options to a larger population of RA patients having moderate to severe disease and who are inadequately controlled on one or the other DMARDs.
This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with active RA receiving stable and maximum tolerated dose of MTX.
Read more
Patients will be recruited after providing written informed consent. After screening and run in period (single blind placebo for 4 weeks), patients will be randomized (meeting randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium and High) of revamilast or placebo along with MTX.
The primary objective of the study is to determine the percentage of patients achieving ACR20 response at 12 weeks. Secondary objectives include determining percentage of patients with ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and frequency and use of rescue medication.
During the treatment period, there will be 5 further study visits at week 2, week 4, week 8, week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow up visit.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Revamilast, Placebo Comparator
- Keywords
- Anti-inflammatory drugs, DMARD
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevamilastDrug
Tablet, Low dose, Once daily for 12 weeks
RevamilastDrug
Tablet, Medium dose, Once daily for 12 weeks
RevamilastDrug
Tablet, High dose, Once daily for 12 weeks
Placebo ComparatorDrug
Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Medium Dose | Experimental | Medium Dose Revamilast Receives: Drug: Revamilast |
| High Dose | Experimental | High Dose Revamilast Receives: Drug: Revamilast |
| Placebo | Placebo comparator | Matching Placebo in Triple Dummy Format Receives: Drug: Placebo Comparator |
| Low dose | Experimental | Low dose Revamilast Receives: Drug: Revamilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving ACR20 response
Measured: 12 weeks
Secondary outcomes (4)
Percentage of patients achieving ACR50 and ACR 70 response
Measured: 12 weeks
Change in DAS-28 score
Measured: week 12
Change in serum CRP and ESR values
Measured: 12 weeks
Frequency and use of rescue medication
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Dr Lalit Lakhwani, Study director, Glenmark Pharamceuticals SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430507
- Sponsor's protocol ID
- GRC 4039-203
- Other IDs
- 2011-000107-40
- Acronym
- TERRA
- Status last verified
- Aug 2012
- First submitted
- 7 Sep 2011
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, 12 Week Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate Efficacy, Safety and Tolerability of Revamilast in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT01430507
- Acronym / sponsor ID
- TERRA / GRC 4039-203
- Conditions
- Rheumatoid Arthritis
- Keywords
- Anti-inflammatory drugs, DMARD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Sep 2011 (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.
Rheumatoid arthritis (RA) is a systemic autoimmune and chronic inflammatory disease that causes progressive damage to joints of the body, affecting the functional capacity. Effective management of patients with RA requires a multidisciplinary approach. Despite the various combinations, there is a significant population of RA patients who are not responding to these combinations or showing inadequate response to methotrexate alone. Hence, there is a need for a unique combination of drugs targeting different pathological process to yield the best results in those patients where prognosis is poor. Combination of revamilast with first line therapy like methotrexate could provide better treatment options to a larger population of RA patients having moderate to severe disease and who are inadequately controlled on one or the other DMARDs.
This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with active RA receiving stable and maximum tolerated dose of MTX.
Patients will be recruited after providing written informed consent. After screening and run in period (single blind placebo for 4 weeks), patients will be randomized (meeting randomization criteria) in 1:2:2:2 ratios to receive either one of three doses (Low, Medium and High) of revamilast or placebo along with MTX.
The primary objective of the study is to determine the percentage of patients achieving ACR20 response at 12 weeks. Secondary objectives include determining percentage of patients with ACR50 and ACR70 response, change in DAS-28 score, change in serum CRP and ESR values and frequency and use of rescue medication.
During the treatment period, there will be 5 further study visits at week 2, week 4, week 8, week 12, for efficacy, safety and tolerability assessment and visit at week 14 will be follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medium Dose | Experimental | Drug: RevamilastMedium Dose Revamilast |
| High Dose | Experimental | Drug: RevamilastHigh Dose Revamilast |
| Placebo | Placebo comparator | Drug: Placebo ComparatorMatching Placebo in Triple Dummy Format |
| Low dose | Experimental | Drug: RevamilastLow dose Revamilast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female ≥18 to ≤ 65 years of age
- Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR)
- Active RA defined as patients with:
- DAS-28 CRP values ≥ 4.5 at screening (visit 1)
- Patients must have been on stable (15 mg to 25 mg) or maximum tolerated dose of MTX for at least 12 weeks prior to screening
Key exclusion criteria (14 listed)
- Diagnosis of RA prior to 16 years of age (Juvenile RA)
- Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA
- Patients with any other autoimmune rheumatic disorders with the exception of Sjogren's syndrome.
- Patients with first degree relative with immune deficiency
- History of infection with human immunodeficiency virus and/or active hepatitis B or C
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 |
|---|---|---|
| RevamilastTablet, Low dose, Once daily for 12 weeks | Drug | Low dose |
| RevamilastTablet, Medium dose, Once daily for 12 weeks | Drug | Medium Dose |
| RevamilastTablet, High dose, Once daily for 12 weeks | Drug | High Dose |
| Placebo ComparatorMatching Placebo in triple dummy format, Tablet, Once daily for 12 weeks | Drug | Placebo |
Primary outcome
Percentage of patients achieving ACR20 response
Time frame: 12 weeks
4 secondary outcomes
Percentage of patients achieving ACR50 and ACR 70 response
Time frame: 12 weeks
Change in DAS-28 score
Time frame: week 12
Change in serum CRP and ESR values
Time frame: 12 weeks
Frequency and use of rescue medication
Time frame: 12 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 28 Dec 2012.
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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.
Dr Lalit Lakhwani study director
Glenmark Pharamceuticals SA
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revamilast in people with Rheumatoid Arthritis, run by Glenmark Pharmaceuticals Ltd. India at 36 sites in 5 countries.
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 21 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 28 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India, Philippines, Poland, Sri Lanka, United Kingdom. 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 achieving ACR20 response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2012.