An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone

ClinicalTrials.gov ID

NCT01664117

Acronym / sponsor ID

ML28356

Conditions

Rheumatoid Arthritis

Study type

Observational

Recruitment status

Completed

Enrolment

210 participants (actual)

Lead sponsor

Hoffmann-La RocheIndustry (pharma, biotech, devices)

Study start

Jun 2012

Primary completion

Jun 2013 (actual)

Study completion

Jun 2013 (actual)

First posted

14 Aug 2012 (estimated)

Results

Posted 4 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Cross-sectional

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Patients with moderate to severe rheumatoid arthritis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Number of Participants With Level of Education Completed

   Time frame: At Visit 1 (Single visit study)

   Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)

2. Number of Participants With Smoking Habits

   Time frame: At Visit 1

   Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.

3. Smoking-habit for Smokers or Ex-smokers (Packs in Years)

   Time frame: At Visit 1

   Smoking-habit included number of pack per years is reported.

4. Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )

   Time frame: At Visit 1

   Smoking-habit included years of smoking/quit smoking is reported for participants.

5. Mean Time of Onset of Rheumatoid Arthritis

   Time frame: At Visit 1

   Onset of rheumatoid arthritis is a component of clinical characteristics.

6. Number of Participants With Family History of Rheumatoid Arthritis

   Time frame: At Visit 1

   Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.

7. Number of Participants With Co-morbidities

   Time frame: At Visit 1

   Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.

8. Number of Participants With Extra-articular Manifestations at Visit 1

   Time frame: At Visit 1

   Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.

9. Mean Number of Painful and Swollen Joints at Visit 1

   Time frame: At Visit 1

   Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.

10. Physician's Global Assessment of Disease Activity at Visit 1

    Time frame: At Visit 1

    The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

11. Patient's Global Assessment of Disease Activity at Visit 1

    Time frame: At Visit 1

    Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).

12. Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1

    Time frame: At Visit 1

    Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.

13. Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1

    Time frame: At Visit 1

    Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.

14. Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies

    Time frame: At Visit 1

    Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.

15. Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1

    Time frame: At Visit 1

    The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.

16. Patient Pain Visual Analog Scale Score at Visit 1

    Time frame: At Visit 1

    Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"

17. Number of Participants With Joint Damage at Visit 1

    Time frame: At Visit 1

    Number of participants with joint damage is recorded as yes and no.

18. Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1

    Time frame: At Visit 1

    Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.

19. Number of Participants With Disease Activity Score by Categorization at Visit 1

    Time frame: At Visit 1

    DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.

20. Mean Score on Clinical Disease Activity Index at Visit 1

    Time frame: At Visit 1

    Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.

21. Number of Participants With Clinical Disease Activity by Categorization at Visit 1

    Time frame: At Visit 1

    CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.

22. Mean Score on Simple Disease Activity Index at Visit 1

    Time frame: At Visit 1

    Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.

23. Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1

    Time frame: At Visit 1

    SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

41 sites in 1 country: see every site and its status.