AzTrials
AzTrials

Rheumatoid ArthritisPhase 4PARISNCT02731560

Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)

A Phase 4 study testing Rituximab in people with Rheumatoid Arthritis, run by Prof. Abid Z. Farooqi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A study to determine the efficacy and safety of rituximab in Pakistani patients with rheumatoid arthritis (RA) who have been inadequately controlled with standard disease modifying anti rheumatic drugs (DMARDs). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
No sites listed yet
Study dates
Jan 2010to Dec 2012
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able and willing to give written informed consent.
  • Men and women aged 18-80 years, inclusive.
  • Patients with RA for at least 6 months.
  • DAS28 score > 3.70 at baseline.
  • Inadequate response to methotrexate (MTX), for at least 4 weeks using a stable dose of 15mg/week. Glucocorticoids (<10 mg/day prednisone or equivalent) permitted if stable for at least 4 weeks prior to baseline.
  • Use of Non-steroidal anti-inflammatory drugs (NSAIDs) permitted if stable dose for at least 2 weeks prior to baseline.
  • Patients of reproductive potential (males and females) must be willing to use a reliable method of contraception (e.g. contraceptive pill, intrauterine device (IUD) or a physical barrier) during the study and for 12 months after last Rituximab administration.
  • If female and of childbearing potential, a negative serum pregnancy test within 2 weeks prior to baseline.

Who cannot join

  • Bed bound or wheelchair bound patients.
  • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
  • Exclusions Related to Medications
  • History of severe allergic or anaphylactic reactions to a biologic agent or known hypersensitivity to any component of Rituximab or to murine proteins.
  • Previous treatment with any approved or investigational biologic agent for RA.
  • Concurrent treatment with any biologic agent for any indication.
Show all 26Show fewer
  • Receipt of any vaccine within 4 weeks prior to baseline (it was recommended that a patient's vaccination record and the need for immunization prior to receiving Rituximab should be carefully investigated).
  • Intolerance to or contraindications to drugs required for the treatment of adverse event of Rituximab (e.g., paracetamol, anti-histamines, hydrocortisone, anti-emetics or histamine-receptor 1 (H1) blockers).
  • Intra-articular or parenteral glucocorticoids within 4 weeks prior to baseline.
  • Exclusions for General Safety/Health
  • Any surgical procedure, including bone / joint surgery / synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of randomization.
  • Evidence of any severe or significant medical condition(s) or disease(s) that, in the view of the investigator, prohibited participation in the study.
  • Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator's opinion, would have precluded patient participation.
  • Significant cardiac (heart failure of New York Heart Association (NYHA) class IV) or pulmonary disease (including obstructive pulmonary disease).
  • Known active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections), or a known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 4 weeks prior to baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
  • History of serious recurrent or chronic infection. (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening).
  • Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency (HIV) infection.
  • Pregnancy or breast feeding.
  • Known history of active cancer during the past 5 years, including solid tumours, hematological malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline.
  • Positive serum human chorionic gonadotropin measured within two weeks prior to the first infusion of study drug
  • Positive test for hepatitis B surface antigen (HBsAg) or for hepatitis C serology
  • Positive hepatitis B core antibody (HBcAb) associated with positive hepatitis B virus (HBV) detection (> 29 IU/L or > 169 copies/mL)
  • Hemoglobin < 8.0 g/dL
  • Absolute neutrophil count < 1.5 × 103/μL
  • Concentration of serum immunoglobulin G (IgG) and/or immunoglobulin M (IgM) below 5.0 and 0.40 mg/mL, respectively.

About this study

Official title: Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)

A study to determine the efficacy and safety of rituximab in Pakistani patients with rheumatoid arthritis (RA) who have been inadequately controlled with standard disease modifying anti rheumatic drugs (DMARDs).

Read the detailed description

Enrolled subjects with inadequately-controlled RA had their disease activity level assessed before initiation of therapy and at intervals of 6 months and 12 months thereafter. Standardized disease activity scores like the Disease Activity Score-28 (DAS 28) were used for determining remission or otherwise of the disease. The American College of Rheumatology (ACR) 20, 50 and 70 response scores and the European League of Associations for Rheumatology (EULAR) Response Criteria for RA were used to determine the percentage improvement in the individual subject's condition at the same intervals. The former utilizes a set of assessments to determine if, after a given therapy, there has been a 20, 50 or 70% improvement in the aggregate scores as compared to the baseline and the latter utilizes calculated improvements in the DAS 28 score to determine if the response to treatment has been good, moderate or none. Both of these have been validated and approved for use by the ACR and EULAR respectively.

The study enrollment period was from 1st January 2010 till 31st December 2010. Observation period was 12 months from the enrollment date for each subject. The final results are being reported here.

Being tested
Rituximab
Keywords
Pakistan, Rituximab, RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called RTX

    Rituximab was administered as an intravenous infusion as per approved protocol on Day 1 and day 14. The protocol stipulated the administration of intravenous hydrocortisone 100 mg and oral pheniramine maleate 43.5 mg as pre-medication. The Rituximab itself was given as a 1 gm infusion slowly over a period of 4-6 hours.

    This was done either by a specialist nurse or a trained doctor.

Study groups in NCT02731560
Study groupRoleWhat they receive
Single ArmOtherTreatment with Rituximab in RA patients showing inadequate response to standard DMARDs
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in Disease Activity Assessment Score (DAS-28)

    To determine the percentage of previously inadequately-controlled RA patients achieving improvement in their disease activity level post treatment with Rituximab at 6 months interval using Disease Activity Score in 28 selected joints (DAS-28).

    Measured: 6 months

Secondary outcomes (4)

  1. Status of disease activity level using DAS 28 score

    To determine the percentage of such RA patients achieving improvement in their disease activity level post treatment at 12 months interval using DAS-28.

    Measured: 12 months

  2. Status of disease response to treatment using the ACR 20/50/70 response criteria

    Using the ACR 20/50/70 response criteria

    Measured: 12 months

  3. Status of disease response to treatment using the EULAR response criteria

    using the EULAR response criteria

    Measured: 12 months

  4. Documenting serious adverse events during the trial period

    Any event leading to hospitalization or death during the trial period

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2016 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2011
  4. Study completionDec 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02731560
Sponsor's protocol ID
ML25190
Acronym
PARIS
Status last verified
Apr 2016
First submitted
6 Mar 2016
Last updated
7 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rituximab in people with Rheumatoid Arthritis, run by Prof. Abid Z. Farooqi.

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 8 inclusion and 26 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: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Disease Activity Assessment Score (DAS-28) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02731560.

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 7 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in