A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis
TERRA
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
2 other identifiers
interventional
406
5 countries
36
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Sep 2011
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 28, 2012
August 1, 2012
1.3 years
September 7, 2011
December 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients achieving ACR20 response
12 weeks
Secondary Outcomes (4)
Percentage of patients achieving ACR50 and ACR 70 response
12 weeks
Change in DAS-28 score
week 12
Change in serum CRP and ESR values
12 weeks
Frequency and use of rescue medication
12 weeks
Study Arms (4)
Medium Dose
EXPERIMENTALMedium Dose Revamilast
High Dose
EXPERIMENTALHigh Dose Revamilast
Placebo
PLACEBO COMPARATORMatching Placebo in Triple Dummy Format
Low dose
EXPERIMENTALLow dose Revamilast
Interventions
Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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:
- swollen joint counts
- 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
- 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:
- +6 more criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glenmark Pharmaceuticals Ltd. Indialead
- Glenmark Pharmaceuticals S.A.collaborator
Study Sites (36)
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, 700020, 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, 01-868, 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, 50-403, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr Lalit Lakhwani
Glenmark Pharamceuticals SA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 8, 2011
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 28, 2012
Record last verified: 2012-08