CTRI

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CTRI Number

CTRI/2025/08/092889 [Registered on: 12/08/2025] Trial Registered Prospectively

Last Modified On:

04/05/2026

Post Graduate Thesis

Type of Trial

PMS

Type of Study

Drug
Biological

Study Design

Single Arm Study

Public Title of Study

To evaluate the safety and effectiveness of GolimuRel in patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ulcerative Colitis. Golimurel will be administered in a total of 225 patients of these three indications and safety profile will be be evaluated as primary outcome in these patients.

Scientific Title of Study

A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of GolimuRel® (Golimumab manufactured by Reliance Life Sciences Pvt. Ltd.) in rheumatoid arthritis, psoriatic arthritis and ulcerative colitis

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
RLS/PMS/2023/04; Version 4.0, Dated: 08 Oct 2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ajaykumar Yadav
Designation	AVP & Head Clinical Research Group
Affiliation	Reliance Life Sciences
Address	RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 Mumbai MAHARASHTRA 400701 Mumbai MAHARASHTRA 400701 India Thane MAHARASHTRA 400701 India
Phone	919820804218
Fax
Email	Ajaykumar2.Yadav@relbio.com

Details of Contact Person
Scientific Query

Name	Dr Sachin Kagane
Designation	Medical Monitor
Affiliation	Reliance Life Sciences
Address	RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 Mumbai MAHARASHTRA 400701 Thane MAHARASHTRA 400701 India
Phone	919987885679
Fax
Email	Sachin1.Kagane@relbio.com

Details of Contact Person
Public Query

Name	Mr Ganesh Bagul
Designation	Head- Clinical Operations
Affiliation	Reliance Life Sciences
Address	RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 Mumbai MAHARASHTRA 400701 Thane MAHARASHTRA 400701 India
Phone	919820617721
Fax
Email	Ganesh1.Bagul@relbio.com

Source of Monetary or Material Support

Reliance Life Sciences Pvt Ltd

Primary Sponsor

Name	Reliance Life Sciences Pvt Ltd
Address	Reliance Life Sciences Pvt. Ltd.,Dhirubhai Ambani Life Sciences Centre,Plot no. R-282, TTC area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai – 400710, Maharashtra, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 24
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Danveer Bhadu	All India Institute of Medical Sciences	Room no- 477, Department- Department of Rheumatology, Division- NA,Ansari Nagar, New Delhi- 110029, India. New Delhi DELHI	9005493660 danveerbhadu2000@gmail.com
Dr Vineet Ahuja	All India Institute of Medical Sciences	Room no- NA, Department- NA, Division- NA,Ansari Nagar, New Delhi- 110029, India. New Delhi DELHI	9810707170 vineet.aims@gmail.com
Dr Vishnu Sharma	Amber Clinic	Room- 401-402,Department NA, Division NA, 4th floor, Santorini Square, Opp star Bazzar, Behind Abhishree complex, Near Jodhpur cross road, Satellite Road, Ahmedabad- 380015 Ahmadabad GUJARAT	8511555477 drvishnusharma@yahoo.co.in
Dr Syamasis Bandyopadhyay	Apollo Gleneagles Hospital	Room no- NA, Department of Internal Medicine and Rheumatology, Division NA 58 Canal Circular Road Kolkata 700054 West Bengal, India Kolkata WEST BENGAL	9836576602 sambando@yahoo.co.uk
Dr Pravin Jadav	Assured Care Plus Hospital	Room no NA, Department NA, Division NA, 4th& 5th floor, star plus complex , lam road, Muktidham temple, opp, to divisional office, Nashik road, Nashik, Maharashtra ,422101 , India Nashik MAHARASHTRA	9822055612 drpraveenjadhav@rediffmail.com
Dr Dawesh Yadav	Banaras Hindu University	Room no 23, Department of Gastroenterology, Division: NA, Sir Sundarlal Hospital, New Building, Lanka, Varanasi- 221005, Uttar Pradesh, India. Varanasi UTTAR PRADESH	8130856563 davesh.thedoc@gmail.com
Dr Chandrashekhar Srikantia	ChanRe Rheumatology and Immunology center & Research	Room no 65, Department NA, Division NA, Metro station, 414, 20th Main Rd, near Rajajinagar, West of Chord Road 2nd Stage, Rajajinagar, Bengaluru, 560010, Karnataka, India Bangalore KARNATAKA	9845071151 Chandrashekara_s@yahoo.com
Dr V Krishnamurthy	Chennai Meenakshi Multispecialty Hospital	Room no NA, Department NA, Division NA, Old building no. 149, New no. 72, Luz Church Road, Mylapore, Chennai - 600004, Tamil Nadu, India Chennai TAMIL NADU	9841041717 drvk56@gmail.com
Dr Ksheetij Kothari	CIMET’S Inamdar Multispeciality Hospital	Room no:15, Department: NA, Division: NA, Behind KPCT mall, Fatima Nagar, Wanawadi, Pune-411040, Maharashtra, India Pune MAHARASHTRA	9765180182 ksheetij.kothari@gmail.com
Dr Vinay Kumar	GSVM Medical College	Room no- NA, Department- NA, Division- NA, Swaroop Nagar, Kanpur- 208002, Uttar Pradesh, India. Kanpur Dehat UTTAR PRADESH	7887273354 Drvinakumar011@gmail.com
Dr Nikunj Dadhaniya	Health1 Super Speciality Hospital	Room No. NA, Department NA, Division NA, Block C ,GF To 8 Floor, Shilaj 23/73, On S.P.Ring Road, Near Shilaj Circle, Shilaj. Ahmedabad Ahmedabad Gujarat - 380059 India Ahmadabad GUJARAT	9712999726 nikunjvdadhaniya@gmail.com
Dr Parasar Gosh	Institute of Post Graduate Medical Education & Research	Room no. 244,Department NA, Division NA, A.J.C. Bose Road, Kolkata- 700020, West Bengal, India. Kolkata WEST BENGAL	9433988317 drparasar@gmail.com
Dr Dnyaneshwar Halnore	Kasturi Medicare Pvt. Ltd	Room no NA, Department NA, Division NA, Harshniketan, Gaondevi Road, Behind Navrang Hotel, Bhayander (W) Mumbai MAHARASHTRA	8976253447 drhalnorpolaris@gmail.com
Dr V Satya Prasad	King George Hospital	Room no NA, Department NA, Division NA, Maharanipta, Visakhapatnam 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH	9393104578 drvsatyaprasadresearch@gmail.com
Dr Girish Kakade	Lifepoint Multispecialty Hospital	Room no.145/1, Department NA, Division NA, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune 411 057, Maharashtra, India Pune MAHARASHTRA	99752 59101 patilnj81@gmail.com
Dr Shweta Khopade	Medipoint Hospital Pvt. Ltd	Room No. 241/1, Department NA, Division NA, New D. P. Road, Aundh: 411007, Maharashtra, India Pune MAHARASHTRA	9594340931 drgirishk.medipoint@gmail.com
Dr Araghya Chatopadhyay	North Bengal Medical College & Hospital	Room no NA, Department NA, Division NA, Sushruta nagar, Siliguri, Darjeeling, West Bengal 734012, India Darjiling WEST BENGAL	9434198949 dr.arghyact21@gmail.com
Dr Kunal Patil	Om Sai Onco Surgery Multispeciality Center	Room no 457/10 C ,Dr. Lad Colony, Department NA, Division NA, Sugar Mill corner, Main Road, Kasaba Bawada, Kolhapur-416006. Maharashtra, India. Kolhapur MAHARASHTRA	8149839175 drkunal.crd@gmail. com
Dr Aniruddha Tembhe	Oyster and Pearl Hospital	Room no. 1671- 75, Department NA, Division NA, Shivajinagar, Ganeshkhind road, Shivajinagar, Pune- 411005, Maharashtra, India Pune MAHARASHTRA	8975751707 draniruddhatembe@gmail.com
Dr Vaishali Bhardwaj	R.M.L. Hospital	Room no- 404, Department of Gastroenterology, Division: NA, Academic Block, 4th Floor, PGIMER R.M.L Hospital, Baba Kharag Singh Marg, New Delhi -110001, India. New Delhi DELHI	8376022402 drvaishali22.db@gmail.com
Dr Diwakar Sharma	Radha Krishna Critical Care and General Hospital	Room no- NA, Department: NA, Division: NA, 1-C-12, Sheela Chaudhary Road, Talwandi, Kota- 324005, Rajasthan, India. Kota RAJASTHAN	8949797325 drdiwakartrial@gmail.com
Dr Avinash Agrawal	Shri Nidan Hospital and Hope Fertility Centre	Room no-NA, Department: NA, Division NA, 27- Vidyut Nagar A, Ajmer Road, Jaipur- 302021, Rajasthan, India. Jaipur RAJASTHAN	9829052451 dravitrial@gmail.com
Dr Avinash Jain	SMS Medical College & Attached Hospitals	JLN Marg Jaipur -Rajasthan -302004 India Jaipur RAJASTHAN	8980005584 avipatni@gmail.com
Dr Make Naveen Chand	Visakha Institute of Medical Sciences	Room no: NA, Department of Medical Gastroenterology, Division: NA, Visakha Institute of Medical Sciences (VIMS), Hanumanthavaka, Chinnagadhili, Visakhapatnam-530040, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH	9885837772 drmnaveenchandresearch@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 22
Name of Committee	Approval Status
CMMHEC, Chennai Meenakshi Multispeciality Hospital Limited	Approved
Ethics Committe Inamdar Multispeciality Hospital	Approved
Ethics Committee GSVM Medical College	Approved
Health1 super speciality hospital EC Health 1 Super Speciality Hospital	Submittted/Under Review
IEC King George Hospital	Submittted/Under Review
Institute Ethics Committee All India Institute of Medical Sciences	Approved
Institute Ethics Committee All India Institute of Medical Sciences	Approved
Institutional Ethics Committee	Submittted/Under Review
Institutional Ethics Committee Apollo Gleneagles Hospital	Submittted/Under Review
Institutional Ethics Committee North Bengal Medical College And Hospital	Submittted/Under Review
Institutional Ethics Committee Shlok Superspecialty Care	Submittted/Under Review
Institutional Ethics Committee – CRICR	Submittted/Under Review
Institutional Ethics Committee- Visakha Institute of Medical Sciences (VIMS)	Approved
IPGMER Oversight Committee	Approved
Kota Institutional Ethics Committee, Radha Krishna Critical Care and General Hospital	Approved
Lifepoint Research- Ethics Committee	Approved
O and P Ethics Committee	Approved
Office of the Ethics Committee, SMS Medical College and attached Hospitals	Approved
Om Sai Onco Institutional Ethics Committee	Submittted/Under Review
Penta-Med Ethics Committee Medipoint Hospitals Pvt. Ltd	Approved
Sangini Hospital Ethics Committee	Submittted/Under Review
Shah Lifeline Hospital And Heart Institute Ec Shah Lifeline Hospital And Heart Institute Pvt Ltd	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M069\|\|Rheumatoid arthritis, unspecified, (2) ICD-10 Condition: K519\|\|Ulcerative colitis, unspecified, (3) ICD-10 Condition: L405\|\|Arthropathic psoriasis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	GolimuRel®	Golimumab (50mg) L-Histidine and L-Histidine monohydrochloride monohydrate (0.44mg) Polysorbate- 80 (0.08mg) Sorbitol (20.5mg) Water for injection qs to 0.5 ml 50 mg subcutaneously every 4 weeks at week 0, 4, 8, 12, 16 and 20 for Rheumatoid arthritis and Psoriatic arthritis. 200 mg initially administered by subcutaneous injection at Week 0 followed by 100 mg at Week 2 and then 100 mg at Week 6, 10, 14, 18 and 22 for Ulcerative colitis
Comparator Agent	Not Applicable	Not Applicable

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1 Patients with rheumatoid arthritis psoriatic arthritis or ulcerative colitis as defined below Rheumatoid Arthritis Males and females aged 18 to 65 years inclusive 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 Subjects must have ACR or EULAR diagnostic criteria score greater than or equal to 6 Subjects must have active disease as defined by Greater than or equal to 6 swollen joints Greater than or equal to 6 tender joints and Acute phase reactant values CRP greater than 8 mg per L or ESR greater than 28 mm per h Subject must have been treated with and tolerated MTX at a dose of at least 20 mg per week for at least 3 months prior to screening and have a stable MTX dose of greater than or equal to 20 mg per week and less than or equal to 25 mg per week for at least 4 weeks prior to first administration of study drug. Subjects using oral corticosteroids must have been on a stable dose equivalent to less than or equal to 10 mg of prednisone per day for at least 2 weeks prior to first administration of study drug If currently not using corticosteroids the subject must not have received oral corticosteroids for at least 2 weeks prior to first administration of study drug 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 drug Patients must be considered eligible according to the following TB screening criteria Have no history of latent or active TB prior to screening Have no signs or symptoms suggestive of active TB upon medical history and per or physical examination. 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 Have no evidence of latent TB based on tuberculin skin Mantoux test QuantiFERON TB Gold test or other tuberculosis screening tests performed during screening Have no evidence of current active TB or old inactive TB based on chest radiograph at screening Screening laboratory test results Hemoglobin greater than or equal to 8.0 g per dL White blood cells greater than or equal to 3.5 into 109 per L Neutrophils greater than or equal to 1.5 into 109 per L Platelets greater than or equal to 100 into 109 per L ALT and AST levels less than or equal to 2 times the ULN Serum creatinine less than or equal to 150 µmol per L less than or equal to 1.7 mg per dL Psoriatic Arthritis Patients aged 18 years or older Active psoriatic arthritis greater than or equal to 3 swollen joints and greater than or equal to 3 tender joints in at least one of the following forms 1 DIP which is Distal interphalangeal involvement 2 Polyarticular arthritis absence of rheumatoid nodules and presence of psoriasis 3 Arthritis mutilans 4 Asymmetric psoriatic arthritis 5 Spondylitis like ankylosis Patients with plaque psoriasis with a lesion greater than or equal to 2 cm in diameter Ulcerative Colitis UC Patients aged 18 years or older Has a clinical diagnosis of Ulcerative Colitis UC at least 3 months prior to screening Has a current UC severity that is judged by the treating physician to be moderate to severe being a partial Mayo score of 5 to 9 inclusive Participants must have biopsy results collected at the screening endoscopy procedure or obtained within the last 1 year prior to screening consistent with the diagnosis of UC Participants either currently receiving treatment with or have a history of failure to respond to or tolerate at least 1 of the following therapies oral 5 aminosalicylate oral corticosteroids 6-mercaptopurine and azathioprine Participants with current dependency or with a history of corticosteroid dependency that is an inability to successfully taper corticosteroids without a return of the symptoms of UC 2 Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures eg 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 3 Menopausal females must have experienced their last period more than 12 months prior to screening to be classified as not of childbearing potential 4 Subject must be capable of providing informed consent which must have been obtained prior to any study related procedures 5 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

ExclusionCriteria

Details

If patients have any of the following conditions they are not eligible to participate in the study
1 Patients with hypersensitivity to golimumab or any component of the formulation Chinese hamster ovary cell products or other recombinant human or humanized antibodies
2 Inflammatory diseases other than RA that might confound the evaluation of the efficacy of golimumab eg psoriatic arthritis ankylosing spondylitis systemic lupus erythematosus or Lyme disease for RA only
3 Received infliximab adalimumab etanercept certolizumab tocilizumab rituximab or golimumab or any biological treatment of Rheumatoid Arthritis psoriatic arthritis or ulcerative colitis
4 Received DMARDs per systemic immunosuppressives eg leflunomide Dpenicillamine hydroxychloroquine chloroquine oral or parenteral gold sulfasalazine azathioprine cyclosporine mycophenolate mofetil anakinra or intraarticular IM or IV corticosteroids including adrenocorticotropic hormone within the 4 weeks prior to the first administration of study drug
5 Subjects with prior and current use of anakinra abatacept or biologic antitumor necrosis factor TNF agents
6 Participants with severe extensive UC that is likely to require a colectomy surgery to remove part or all of the colon within 12 weeks of study entry for UC only

Participants having UC limited to the rectum only or to less than 20 centimeter of the colon for UC only
9 Presence of a stoma an artificial permanent opening especially in the abdominal wall made in surgical procedures or presence of a fistula for UC only
10 Received any investigational drug within 5 halflives prior to the first administration of study drug
11 Received herbal homeopathic ayurvedic or traditional medicines for rheumatoid arthritis psoriatic arthritis or ulcerative colitis within 1 months prior to the first administration of the study drug
12 History of or ongoing chronic or recurrent infectious disease including but not limited to chronic renal infection chronic chest infection eg bronchiectasis sinusitis recurrent urinary tract infection eg recurrent pyelonephritis chronic nonremitting cystitis an open draining or infected skin wound or an ulcer
13 History of a serious infection eg hepatitis pneumonia pyelonephritis or sepsis which caused hospitalization within 6 months prior to the first administration of the study drug or treated with IV antibiotics for an infection within 2 months prior to administration of study drug
14 Positive HIV HBsAg or HCV test at screening
15 History of active or latent granulomatous infection including TB histoplasmosis or coccidioidomycosis
16 Had a nontuberculous mycobacterial infection or opportunistic infection eg cytomegalovirus Pneumocystis carinii aspergillosis within 6 months prior to screening
17 Received or is expected to receive any live virus or bacterial vaccination within 3 months before the first administration of study drug or within 6 months after the last administration of study drug
18 Received or is expected to receive Bacille CalmetteGuerin BCG vaccination within 12 months before the first administration of study drug or within 6 months after the last administration of study drug
19 History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease eg lymphadenopathy of unusual size or location or clinically significant splenomegaly
20 Known history of malignancy or organ transplantation
21 Presence of any abnormality suggestive of a malignancy or current active infection including TB based on chest radiograph at screening
22 Known history of demyelinating disease such as multiple sclerosis or optic neuritis

23 Known history or current evidence of CHF
24 Known history of asthma COPD or any other clinically significant respiratory disease
25 Current signs or symptoms of severe progressive or uncontrolled renal hepatic hematologic gastrointestinal endocrine pulmonary cardiac neurologic psychiatric or cerebral disease
26 Known hypersensitivity to human immunoglobulin proteins or other components of golimumab
27 Had a substance abuse drug or alcohol problem within the previous 3 years
28 Participation in any clinical study of an investigational product within the previous 3 months
29 Pregnant nursing or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study drug

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Incidence of adverse events occurring during the study.	Rheumatoid Arthritis & Psoriatic Arthritis - Screening, Day 0, Weeks 4, 8, 12, 16, 20 and 24 Ulcerative Colitis - Screening, Day 0,Week 2 Weeks 6, 10, 14, 18, 22 and 24

Secondary Outcome

Outcome	TimePoints
Proportion of patients with an ACR 20, ACR 50 and ACR 70 response at each visit through Week 24	Weeks 4, 8, 12, 16, 20 and 24
Change from baseline in DAS 28 score at each visit through Week 24	Week 24
Change from baseline in CRP and ESR level at each visit through Week 24	Week 24
Change from baseline in HAQ-DI score at each visit through Week 24	Week 24
Improvement from baseline in Short Form 36 Health Survey Questionnaire (SF-36) score at Week 24	Week 24
Proportion of patients achieving the ACR 20, 50, and 70 response across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)	Weeks 4, 8, 12, 16, 20 and 24
Proportion of patients achieving PASI 50/75/90/100 response from baseline across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)	Weeks 4, 8, 12, 16, 20 and 24
Change in HAQ-DI score from baseline across visits (i.e., at Weeks 4, 8, 12, 16, 20 and 24)	Weeks 4, 8, 12, 16, 20 and 24
Number of patients with Clinical Response at Week 10 and 24	Week 10 and 24
Number of patients with Clinical Remission at Week 10 and 24	Week 10 and 24
Number of patients with Mucosal Healing at Week 10 and 24	Week 10 and 24
Rheumatoid arthritis & Psoriatic Arthritis: Immunogenicity assessment at Weeks 0, 12 and 24 or withdrawal visit	Weeks 0, 12 and 24 or withdrawal visit
Ulcerative colitis: Immunogenicity assessment at Weeks 0, 10 and 24 or withdrawal visit	Weeks 0, 10 and 24 or withdrawal visit

Target Sample Size

Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Post Marketing Surveillance

Date of First Enrollment (India)

25/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="4"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of GolimuRel^®in approved indications. In this study, a total of 225 patients with 75 patients in moderate to severe active rheumatoid arthritis, 75 patients moderate to severe psoriatic arthritis and 75 patients in moderate to severe ulcerative colitis will be enrolled to ensure 202 evaluable patients (considering a drop-out rate of 10%).