Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT02296775
Last Updated: 2020-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
276 participants
INTERVENTIONAL
2014-11-30
2017-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DRL_RI
DRL_RI
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
Rituxan
Rituxan
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
MabThera
MabThera
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
Interventions
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DRL_RI
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
Rituxan
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
MabThera
Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of RA, according to ACR criteria (1987), of at least 6 months duration
3. At randomization, tender joint count ≥ 6 and swollen joint count ≥ 6
4. Evidence of at least moderate disease activity
5. Patients receiving oral or parenteral MTX with a dose of 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic DMARD(s) for at least 6 months and on stable dose for at least 3 months
6. Patients must be on a stable dose of folic acid or equivalent (≥5 mg per week)
7. Chest X-ray not suggestive of any lung infections including pulmonary tuberculosis (TB)
8. Contraception required per protocol
Exclusion Criteria
* Rituximab, abatacept, tocilizumab, anakinra or an agent/antibody targeting CD20, CD19 or B cells
* Tumor necrosis factor (TNF) alfa antagonists or other biologic DMARDs
Other prior or concurrent therapies may also be excluded
2. Any clinically relevant abnormality detected on screening history, physical examination, clinical laboratory, chest X-ray, or electrocardiogram (ECG), other than values consistent with RA
3. Evidence of active, suspected or inadequately treated TB
4. Positive serological test for hepatitis C virus antibodies, hepatitis B surface antigen, hepatitis B core antibody, or human immunodeficiency virus
5. History of cardiovascular disease, history of stroke, or uncontrolled hypertension
6. History of lymphoproliferative disease or organ allograft
7. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for \>5 years)
8. History of allergy (medication history) to any of the compounds used in the study
9. Pregnant or lactating women or women planning to become pregnant during the study
18 Years
65 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Locations
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Gurunank Care Hospital
Hyderabad, Andhra Pradesh, India
Care Hospitals
Hyderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences Ltd.
Secunderabad, Andhra Pradesh, India
Yashoda Hospital
Secunderabad, Andhra Predesh, India
Shalby Hospitals
Ahmedabad, Gujarat, India
Government Medical College & New Civil Hospital
Surat, Gujarat, India
Chanre Rheumatology & Immunology Center & Research
Bangalore, Karnataka, India
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd
Hubli, Karnataka, India
Jagadguru Sri Shivarathreeshwara Hospital
Mysore, Karnataka, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Mumbai, Maharashtra, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, India
Deennath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
Oyster & Pearl Hospital
Pune, Maharashtra, India
lnamdar Multispeciality Hospital
Pune, Maharashtra, India
Maulana Azad Medical College & Associated Lok Nayak Hospitals
New Delhi, National Capital Territory of Delhi, India
lndraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Dayanand Medical College & Hosptial
Ludhiana, Punjab, India
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Shri Nidaan Hospital & Hope Fertility Centre
Jaipur, Rajasthan, India
Apollo Specialty Hosptials
Madurai, Tamil Nadu, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Communal Healthcare Institution Kharkiv City Clinical Hospital #8
Kharkiv, , Ukraine
State Institution National Scientific Center Acad. Strazhesko Institute of Cardiology of National Academy of Medical Science
Kyiv, , Ukraine
State Institution D.F. Chebotariov Institute of Gerontology of NAMS of Ukraine
Kyiv, , Ukraine
M.V. Sklifosovskyi Poltava Regional Clinical Hospital
Poltava, , Ukraine
Vinnytsia M.I. Pyrogov Regional Clinical Hospital
Vinnytsia, , Ukraine
Medical Clinical Investigational Center MC LLC Health Clinic
Vinnytsia, , Ukraine
Communal Institution Zaporzhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, , Ukraine
Countries
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References
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Haridas VM, Katta R, Nalawade A, Kharkar S, Zhdan V, Garmish O, Lopez-Lazaro L, Batra SS, Kankanwadi S. Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naive Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study. BioDrugs. 2020 Apr;34(2):183-196. doi: 10.1007/s40259-020-00406-1.
Other Identifiers
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RI-01-003
Identifier Type: -
Identifier Source: org_study_id
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