| CTRI Number |
CTRI/2023/03/050776 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a drug (Darbepoetin), on haemoglobin in patients with anaemia of chronic disease due to rheumatoid arthritis |
|
Scientific Title of Study
|
Randomised controlled trial to determine the efficacy of darbepoetin in improving haemoglobin in patients of rheumatoid arthritis with anaemia of chronic disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Kumar |
| Designation |
Associate Professor |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Rheumatology, 4th Floor, Army Hospital (Research & Referral), Delhi Cantonment
South West
DELHI
110010
India |
| Phone |
8800664015 |
| Fax |
|
| Email |
cymarose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kundan Mishra |
| Designation |
Associate professor |
| Affiliation |
Army Hospital (Research and Referral) |
| Address |
Department of Haematology, 4th Floor, Army Hospital (Research & Referral), Delhi Cantonment
North West
DELHI
110010
India |
| Phone |
9871323179 |
| Fax |
|
| Email |
mishrak20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Kumar |
| Designation |
Associate Professor |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Rheumatology, 4th Floor, Army Hospital (Research & Referral), Delhi Cantonment
South West
DELHI
110010
India |
| Phone |
8800664015 |
| Fax |
|
| Email |
cymarose@gmail.com |
|
|
Source of Monetary or Material Support
|
| investigator funded study being conducted at army hospital research and referral Delhi |
|
|
Primary Sponsor
|
| Name |
Army Hospital RR |
| Address |
Dhaula Kuan
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhishek Kumar |
Army Hospital (Research & Referral) |
Department of Rheumatology and Haematology, 4th Floor, Army Hospital (Research & Referral), Delhi Cantonment
South West
DELHI |
8800664015
cymarose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Army Hospital Research and Referral, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darbepoetin with standard of care |
Injection darbepoetin will
be given subcutaneously at the
doses of 50 -100 micrograms every 15 days for total of three months duration. |
| Comparator Agent |
standard of care |
for rheumatoid arthritis as per disease activity status and American College of Rheumatology Guideline 2021 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age>18 yrs.
2. RA (defined by EULAR criteria 2010)
3. Anaemia of chronic disease as defined by
4. Haemoglobin <13g/dl in males and <12 g/dl in females
5. Normocytic normochromic or microcytic hypochromic RBCs on peripheral blood smear (PBS)
6. Normal or high serum ferritin (>50 ng/L)
7. Low/normal TIBC
8. Normal or low transferrin saturation
|
|
| ExclusionCriteria |
| Details |
1. Concomitant additional factor contributing to anaemia like iron or vitamin deficiency, haemolysis etc.
2. Hypertension
3. Chronic organ failure (kidney, heart, liver, lung)
4. History of thromboembolism
5. Splenomegaly
6. Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in haemoglobin in the study group at the end of study period |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to estimate the effect of darbepoetin on disease related outcomes (like swollen joint count (SJC), tender joint count (TJC), patient global assessment of disease (PGA) and disease activity as measured by Disease Activity Score 28 Joints – c-Reactive Protein (DAS28-CRP) |
baseline, 4 weeks, 8 weeks and 12 weeks |
| to estimate the safety of darbepoetin in patients with rheumatoid arthritis |
baseline, 4 weeks, 8 weeks and 12 weeks |
| to estimate the effect of darbepoetin on quality of life as measured by Short Form-36 (SF-36) Health Survey Questionnaire. |
baseline and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included cymarose@gmail.com).
- For how long will this data be available start date provided 01-09-2024 and end date provided 01-09-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
All patients
will undergo baseline clinical and laboratory evaluation. The baseline history
was recorded to include features as enumerated in 2010 ACR/EULAR classification
criteria for rheumatoid arthritis.
Study
design: This is a randomized 2-arm, open-label, phase 3 study. Subjects will be
randomized with equal allocation to receive either (1) standard treatment for
RA or (2) standard treatment for RA plus fortnightly darbepoetin. Randomization
will be performed using computer based algorithm. Standard RA treatment will be
decided by the treating rheumatologist as per the extant guidelines.
For
subjects in the darbepoetin arm, injection darbepoetin will be given
subcutaneously at the doses of 50 -100 mg. It will be given at the
inclusion and thereafter every 15-day for total of three months duration.
In the other arm standard treatment for RA as decided by the clinician will be
administered. At all visits patient will undergo assessments to see the effect
on level of haemoglobin, RA disease activity as measured by DAS-28 CRP score,
and quality of life assessment as measured by SF-36 health survey questionnaire
disease activity of RA. Patients will also undergo assessment to detect any
adverse effect of darbepoetin and DMARDs.
|
|