Severe Plaque Type PsoriasisPhase 4NCT02248792
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
A Phase 4 study testing Methotrexate in people with Severe Plaque Type Psoriasis, run by Narayana Medical College & Hospital at 1 site in India.
Trial summary
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Plaque Type Psoriasis
- What is being tested?
- Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2013to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) -
Who cannot join
- Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Narayana Med College and Hospital
Nellore, Andhra Pradesh, 524003
Avisa Rao, MD
About this study
Official title: Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.
- Conditions
- Severe Plaque Type Psoriasis
- Being tested
- Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Methotrexate 10mg orally once weekly Receives: Drug: Methotrexate |
| Group B | Active comparator | Methotrexate 25mg orally once weekly Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in health related quality of life
Measured: 12 weeks
Secondary outcomes (1)
comparison of improvement in health related quality of life between Group A and Group B
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Plaque Type PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Narayana Medical College & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C V Krishna, Narayana Medical College & Hospital
- Investigators
- C V Krishna, MD, Principal investigator, Narayana Medical college and hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248792
- Sponsor's protocol ID
- NMCHDer
- Status last verified
- Sep 2014
- First submitted
- 22 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.
- ClinicalTrials.gov ID
- NCT02248792
- Acronym / sponsor ID
- NMCHDer
- Conditions
- Severe Plaque Type Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Narayana Medical College & HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: MethotrexateMethotrexate 10mg orally once weekly |
| Group B | Active comparator | Drug: MethotrexateMethotrexate 25mg orally once weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) -
Key exclusion criteria (2 listed)
- Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate | Drug | Group A, Group B |
Primary outcome
Improvement in health related quality of life
Time frame: 12 weeks
1 secondary outcome
comparison of improvement in health related quality of life between Group A and Group B
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Related trials for Severe Plaque Type Psoriasis
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A Clinical Study Evaluating the Efficacy and Safety of CMS-D001 Tablets in the Treatment of Adult Patients With Moderate to Severe Plaque-type Psoriasis
Moderate to Severe Plaque Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C V Krishna, MD principal investigator
Narayana Medical college and hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate in people with Severe Plaque Type Psoriasis, run by Narayana Medical College & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C V Krishna, MD (+91-0413-2655961, vijay_postgradmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in health related quality of life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.