A Study of Methotrexate Tablets 2.5 mg in Adult Patients with Mild to Severe Psoriasis or Rheumatoid Arthritis
- Conditions
- Health Condition 1: L40- PsoriasisHealth Condition 2: M069- Rheumatoid arthritis, unspecified
- Registration Number
- CTRI/2021/08/035480
- Lead Sponsor
- Alembic Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Patient will be eligible for inclusion in this study only if all of the
following criteria apply:
1. Male or non-pregnant, non-lactating female between 18-65 years
of age (both inclusive).
a. Male patient if sexually active with a female of child bearing
potential must agree to use barrier method of contraception
throughout the study period and for at least 3 months after last
dose of study drug.
b. Female of childbearing potential must have a negative serum
pregnancy test performed within 21 days prior to initiation of the study & urine pregnancy test at the time of check-in of
each period.
c. Female patient of childbearing potential must use highly
effective methods of contraception throughout the study
period and agree to continue contraception for at least 6
months after the last dose of study drug.
Acceptable forms of contraception include the following:
i. Intrauterine device in place for at least 3 months prior to
the start of the study and remaining in place during the
study period, or
ii. Barrier methods containing or used in conjunction with
a spermicidal agent, or
iii. Surgical sterilization, or
iv. Practice sexual abstinence throughout the course of the
study.
d. Female will not be considered of child bearing potential if one
of the following is reported and documented in the medical
history:
i. spontaneous amenorrhea for at least one year, or
ii. 6 months of spontaneous amenorrhea with serum FSH
levels >40 mIU/mL, or
iii. at least 6 weeks post-surgery following bilateral
oophorectomy with or without hysterectomy.
2. Patient should have a Body Mass Index (BMI) less than or equal
to 30 but greater than or equal to 18 kg/m2. BMI values should
be rounded to the nearest integer. (e.g. 30.4 rounds to 30, while
17.5 rounds to 18).
3. Patient should have established clinical diagnosis based on the
following criteria at least 6 months prior to study participation:
a. Psoriasis: Confirmed after dermatologic consultation and/or
by biopsy.
b. Rheumatoid Arthritis: Based on the ACR 2010 criteria
4. Patient with mild to severe Psoriasis or Rheumatoid Arthritis
who are already on established regimen of 2.5 mg every 12 hours
(total dose of 7.5mg/week) as 2.5 mg at 12-hour intervals for
three doses at least since the last 3 months.
5. No changes expected in Methotrexate (dose and route) in the 4
weeks prior to randomization and the duration of study.
6. Patient on stable dose (� 5mg per week) of folic acid or folinic
acid supplement for at least 4 weeks prior to randomization and
will remain on same stable dose throughout the study as per
Principal Investigator or co-Investigator judgment.
7. Patient is willing to provide written informed consent and able to
comply with all the study requirements.
8. Patient should be judged eligible by the Principal Investigator or
co-Investigator or physician during the screening visit performed
within 21 days of the first dose of study medication, which
include complete medical history, normal or clinically nonsignificant
clinical examination, labora
Patient will not be eligible for inclusion in this study if any of the
following criteria apply:
1. History of allergic response to Methotrexate or other related
drugs or any of its formulation ingredients.
2. History of lymphoproliferative disease or organ allograft.
3. History of cancer (except for in situ cancer, excised or limited
stage, curatively treated cancer with no sign of disease for > 5
years).
4. Major surgery of the gastrointestinal tract, the liver or kidney
within 4 weeks of study entry (check-in day) which may impact
on the pharmacokinetics of Methotrexate.
5. Patient suffering from ascites or pleural effusion.
6. Patient using concomitant medication listed in Prohibited
medicines (Refer Section 6.5) if are stable on any of the
medication since the last 30 days and in the opinion of Study
Investigator and Medical Monitor, it would not affect the study
objective, then they can continue the same drug (route and dose)
throughout the study period.
Note: If the patient was on any of the prohibited medications outlined in
Section 6.5, sufficient wash out period (of at least 5 half-lives) must have
elapsed since the last dose of such drug and the first dose of study
medication.
7. Patient suffering from alcoholic liver disease or chronic liver
disease.
8. Patient who have pre-existing blood dyscrasias such as bone
marrow hypoplasia, leucopenia, thrombocytopenia or significant
anemia.
9. Any significant disease or condition which might compromise
the haemopoetic, gastrointestinal, renal, hepatic, cardiovascular,
respiratory, central nervous system, endocrine, psychosis or any
other body system.
10. Patient with a positive test result for Hepatitis (includes subtypes
B & C), HIV and/or syphilis (RPR/VDRL).
11. Patient with chest X-ray suggestive of any lung infection
including Pulmonary Tuberculosis (TB).
12. History of cardiovascular disease with New York Heart
Association (NYHA)3 Functional class II or higher or significant
cardiac disease arrhythmias; or history of stroke or uncontrolled
hypertension (systolic blood pressure [BP] � 160 mmHg and
diastolic BP � 95 mmHg).
13. Patient with following laboratory abnormalities will be excluded:
ïâ??· Patient on screening total WBC count <3000Ã?¼L, platelets <
100,000/�¼L, ANC < 1,500�¼L or hemoglobin < 8.5g/dL.
ïâ??· Patient with history of renal trauma, glomerulonephritis, a
single kidney or a creatinine level > 1.5x ULN.
ïâ??· Abnormal liver function tests such as AST, ALT or Alkaline
Phosphatase > 2x ULN.
14. Consumption of grapefruit, grapefruit-like or grapefruit
containing products within 7 days prior to drug administration.
15. Ingestion of any alcoholic, caffeine or xanthine containing food
or beverage, recreational drugs within 48 hour prior to
randomization.
16. Participation in any investigational drug study within 30 days
prior to randomization.
17. Patient with a history of difficulty in swallowing or any
gastrointestinal disease which could affect drug absorption.
18. Donation or loss of blood or pla
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax: Maximum measured plasma <br/ ><br>concentration over the time span specified. <br/ ><br> <br/ ><br>AUC12: The area under the plasma concentration versus time curve will be calculated using the linear trapezoidal rule from the zero time point to the 12 hours. <br/ ><br> <br/ ><br>Note: Extrapolation method will be used for calculation of AUC12 wherever applicable. <br/ ><br>Timepoint: 2 Weeks
- Secondary Outcome Measures
Name Time Method Tmax: Time of the maximum measured plasma concentration. If the maximum plasma concentration occurs at more than one time point, the first is chosen as Tmax.Timepoint: 2 Weeks