This multi-center, randomized, double-blind research study will be conducted to understand the effectiveness and side effects of drug Golimumab (R-TPR-044 / Simponi�®) in patients with active Rheumatoid Arthritis (pain and swelling in joints) on a stable dose of methotrexate.
- Conditions
- Health Condition 1: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2020/09/027958
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1 Males and females, aged 18 to 65 years, inclusive.
2 Diagnosis of Rheumatoid Arthritis according to the criteria based on the revised 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)classification criteria for Rheumatoid Arthritis.
3 Subjects must have ACR/EULAR diagnostic criteria score �6.
4 Subjects must have active disease as defined by:
a �6 swollen joints
b �6 tender joints and
c Acute phase reactant values (CRP >8 mg/L or ESR >28 mm/h)
5 Subject must have been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a stable MTX dose of �15 mg/week and � 25 mg/week for at least 4 weeks prior to first administration of study agent.
6 Subjects using oral corticosteroids must have been on a stable dose equivalent to �10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to first administration of study agent.
7 Subjects using NSAIDs or other analgesics for RA, must have been on a stable dose for at least 2 weeks prior to the first administration of study agent.
8 Patients must be considered eligible according to the following TB screening
criteria:
a Have no history of latent or active TB prior to screening.
b Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
c Have had no recent close contact with a person with active TB or, if there has been such contact, patient should undergo thorough evaluation for TB prior to study enrolment
d Have no evidence of latent TB [based on tuberculin skin (Mantoux) test QuantiFERON�®-TB Gold test or other tuberculosis screening tests performed during screening]
e Have no evidence of current active TB or old inactive TB based on chest radiograph at screening
9 Screening laboratory test results:
a Hemoglobin �8.0 g/dL.
b White blood cells �3.5 x 109/L.
c Neutrophils �1.5 x 109/L.
d Platelets �100 x 109/L.
e ALT and AST levels �2 times the ULN.
f Serum creatinine â�¤150 �µmol/L (â�¤1.7mg/dL)
10 Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures(e.g., abstinence, oral contraceptives,intrauterine device, barrier method with spermicide,surgical sterilization) during the study and for 6 months after receiving the last administration of study drug. Women of childbearing potential must test negative for pregnancy at screening.
11 Menopausal females must have experienced their last period more than 12 months prior to screening to be classified as not of childbearing potential.
12 Subject must be capable of providing informed consent, which must have been obtained prior to any study-related procedures.
13 Subject must be able to understand the study procedures, adhere to the study visit schedule and other protocol requirements, and must be able to complete study-related forms and questionnaires.
1 Inflammatory diseases other than RA that might confound the evaluation of the efficacy of golimumab (e.g., psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease).
2 Received infliximab, adalimumab, etanercept, certolizumab, tocilizumab, rituximab, or golimumab (or any biological treatment of Rheumatoid Arthritis)
3 Received DMARDs/systemic immunosuppressives (e.g., leflunomide, Dpenicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, azathioprine, cyclosporine, mycophenolate mofetil, anakinra, or intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone) within the 4 weeks prior to the first administration of study agent.
4 Subjects with prior and current use of anakinra or abatacept
5 Received any investigational agent within 5 half-lives prior to the first administration of study agent.
6 Received herbal, homeopathic, ayurvedic or traditional medicines for Rheumatoid arthritis within 1 months prior to the first administration of the study agent
7 History of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis),sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic nonremitting cystitis), an open, draining, or infected skin wound, or an ulcer.
8 History of a serious infection (e.g., hepatitis, pneumonia, pyelonephritis, or
sepsis) which caused hospitalization within 6 months prior to the first administration of the study agent or treated with IV antibiotics for an infection within 2 months prior to administration of study agent.
9 Positive HIV, HBsAg or HCV test at screening.
10 History of active or latent granulomatous infection, including TB, histoplasmosis,
or coccidioidomycosis.
11 Had a nontuberculous mycobacterial infection or opportunistic infection (e.g.,
cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to
screening.
12 Received, or is expected to receive any live virus or bacterial vaccination within 3 months before the first administration of study agent or within 6 months after the last administration of study agent.
13 Received or is expected to receive Bacille Calmette-Guerin (BCG) vaccination within 12 months before the first administration of study agent or within 6 months after the last administration of study agent.
14 History of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease (e.g., lymphadenopathy of unusual size or location, or clinically significant splenomegaly).
15 Known history of malignancy or organ transplantation.
16 Presence of any abnormality suggestive of a malignancy or current active infection, including TB based on chest radiograph at screening
17 Known history of demyelinating disease such as multiple sclerosis or optic neuritis.
18 Known history or current evidence of CHF.
19 Known history of asthma, COPD or any other clinically significant respiratory disease.
20 Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease.
21 Known hypersensitivity to human immunoglob
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with an ACR20 responseTimepoint: at week 14
- Secondary Outcome Measures
Name Time Method