NCT03770923

Brief Summary

Effect of Some Drugs on Rheumatoid Arithritis Activity.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
17mo left

Started Oct 2018

Longer than P75 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2018Oct 2027

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

8 years

First QC Date

December 7, 2018

Last Update Submit

December 7, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • se level of IL-17

    change in level of IL-17

    6 months

Study Arms (3)

No intervention

NO INTERVENTION

No intervention

Rupatadine

ACTIVE COMPARATOR

Rupatadine 10 mg once daily.

Drug: Rupatadine

Montelukast

ACTIVE COMPARATOR

Montelukast 10 mg daily

Drug: Montelukast

Interventions

RupatadineDRUG

Rupatadine 10 mg daily

Rupatadine
MontelukastDRUG

Montelukast 10 mg daily

Montelukast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis

You may not qualify if:

  • liver or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, 35111, Egypt

RECRUITING

Related Publications (1)

  • Mostafa TM, Hegazy SK, El-Ghany SEA, Kotkata FAE. Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis. Eur J Clin Pharmacol. 2021 Dec;77(12):1825-1834. doi: 10.1007/s00228-021-03181-2. Epub 2021 Jul 4.

    PMID: 34218304DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

rupatadinemontelukast

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sahar k Hegazy, Prof

    Head of Clinical Pharmacy Department

    PRINCIPAL INVESTIGATOR

  • Tarek M Mostafa, Prof

    Clinical pharmacy Department- Tanta University

    STUDY DIRECTOR

  • Salwa E Abd El-Ghany, Prof

    Rheumatology Dept. - Tanta University

    STUDY CHAIR

  • Fedaa AK Kotkata, Msc

    Clinical pharmacy Department-Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Ph D

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 10, 2018

Study Start

October 1, 2018

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

December 10, 2018

Record last verified: 2018-12

Locations

EG(1)