A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
NCT ID: NCT01430507
Last Updated: 2012-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
406 participants
INTERVENTIONAL
2011-09-30
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Medium Dose
Medium Dose Revamilast
Revamilast
Tablet, Medium dose, Once daily for 12 weeks
High Dose
High Dose Revamilast
Revamilast
Tablet, High dose, Once daily for 12 weeks
Placebo
Matching Placebo in Triple Dummy Format
Placebo Comparator
Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
Low dose
Low dose Revamilast
Revamilast
Tablet, Low dose, Once daily for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Revamilast
Tablet, Low dose, Once daily for 12 weeks
Revamilast
Tablet, Medium dose, Once daily for 12 weeks
Revamilast
Tablet, High dose, Once daily for 12 weeks
Placebo Comparator
Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR)
3. Active RA defined as patients with:
* 6 swollen joint counts
* 6 tender/painful joint counts, and
* At least two of the three following criteria:
* 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
4. DAS-28 CRP values ≥ 4.5 at screening (visit 1)
5. 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
6. The patient's written informed consent to participate in the study
7. Female participants must have a negative serum pregnancy test at screening visit.
8. Males must agree to use barrier while on study medication and for 90 days after taking the last dose of study medication
9. 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
Exclusion Criteria
2. Non-degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA
3. Patients with any other autoimmune rheumatic disorders with the exception of Sjogren's syndrome.
4. Patients with first degree relative with immune deficiency
5. History of infection with human immunodeficiency virus and/or active hepatitis B or C
6. Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients
7. Patients with a history of drug or alcohol abuse or chronic smoking
8. Uncontrolled diabetes mellitus
9. Concurrent diseases that might interfere with the conduct of the study,
10. ECG abnormalities judged by the investigator to be clinically significant
11. History of using any other test drug, one month before the beginning of this trial
12. Women who are pregnant or breast-feeding or on hormonal therapy
13. Patients who in the Investigator's opinion might not be suitable for the study.
14. Patients with a life expectancy of less than 1 year
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glenmark Pharmaceuticals S.A.
INDUSTRY
Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr Lalit Lakhwani
Role: STUDY_DIRECTOR
Glenmark Pharamceuticals SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Advance Rheumatology Clinic
Hyderabad, Andhra Pradesh, India
Mahavir Hospital and Research Center
Hyderabad, Andhra Pradesh, India
Sri Deepti Rheumatology Center
Hyderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India
Rathi Orthopaedic & Research Center
Ahmedabad, Gujarat, India
Shalby Hospitals
Ahmedabad, Gujarat, India
Centre for Knee & Hip Surgery
Vadodara, Gujarat, India
Chanre Rheumatology and Immunology centre and Research
Bangalore, Karnataka, India
M S Ramaiah Medical College and Hospital
Bangalore, Karnataka, India
Kennisha Rheumatology Care & Diagnostics
Mumbai, Maharashtra, India
Sushrut Hospital Research Centre and PG Institute of Orthopaedics
Nagpur, Maharashtra, India
Vidarbha Arthritis & Superspeciality Clinic
Nagpur, Maharashtra, India
Chennai Meenakshi Multispeciality Hospital Limited
Chennai, Tamil Nadu, India
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Institute of Post Graduate Medical Education & Research (IPGMER)
Kolkata, West Bengal, India
Internal Medicine and Rheumatology, Chong Hua Hospital
Cebu, Cebu, Philippines
Brokenshire Memorial Hospital
Davao City, Davao Region, Philippines
Department of Medicine, Davao Doctor's Hospital
Davao City, Davao Region, Philippines
University of Perpetual Help Dalta Medical Center
Las Piñas, National Capital Region, Philippines
Manila Doctors Hospital
Manila, National Capital Region, Philippines
University of Santo Tomas Hospital
Manila, National Capital Region, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines
Oddział Kliniczny Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
NZOZ Reumed
Lublin, Lublin Voivodeship, Poland
Osrodek Badan Klinicznych Prof. Dr hab. med.
Lublin, Lublin Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Medica Pro Familia Sp. z o.o.
Warszawa, Lublin Voivodeship, Poland
Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska
Chełm Śląski, Silesian Voivodeship, Poland
Specjalistyczna Praktyka Lekarska Joanna Badowska
Częstochowa, Silesian Voivodeship, Poland
Wojewodzki Zespol Specjalistycznej Opieki Zdrowotnej
Wroclaw, Silesian Voivodeship, Poland
Colombo South Teaching Hospital
Colombo, Colombo, Sri Lanka
National Hospital of Sri Lnka
Colombo, Colombo, Sri Lanka
Nawaloka Hospitals PLC
Colombo, Colombo, Sri Lanka
Teaching Hospital Karapitiya
Galle, Colombo, Sri Lanka
Queen's Hospital
Romford, Essex, United Kingdom
The Leeds Teaching Hosptial NHS Trust, Chapel Allerton Hospital
Leeds, Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-000107-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GRC 4039-203
Identifier Type: -
Identifier Source: org_study_id