Rheumatoid ArthritisPhase 4VIVIRNCT00761514

Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira

A Phase 4 study testing Humira (adalimumab) in people with Rheumatoid Arthritis, run by Abbott at 10 sites in Puerto Rico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to evaluate quality of life changes in Puerto Rican subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF Monoclonal Antibody. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Humira (adalimumab)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 10 sitesPuerto Rico
Study dates: Nov 2006to Aug 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.
Subject is 18 years of age or older.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD).
contraceptives (oral or parenteral) for three months prior to study drug administration).
a vasectomized partner.

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total abstinence from sexual intercourse.
If female, the results of a serum pregnancy test performed at Screening, prior to the first dose of Humira (adalimumab) must be negative.
Subject has confirmed diagnosis of active rheumatoid arthritis as defined by >= 6 swollen joints and >= 9 tender joints.
Subject has an Erythrocyte Sedimentation Rate (ESR) of > 20 mm/hr. ESR will be measured using the Westergren method.
Subject meets the American College of Rheumatology (ACR) criteria for diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to enrollment and requires to be started in a biologic containing treatment for the first time, and the investigator chooses Humira (adalimumab).
Subject has had unsatisfactory response or intolerance to one or more prior disease-modifying antirheumatic drugs (DMARDS) (e.g., hydroxychloroquine, leflunomide, methotrexate, parenteral gold, sulfasalazine, azathioprine or any combination of those).
Subject will have an evaluation for latent tuberculosis with a tuberculosis (TB) skin test done in the screening visit. Subjects who have evidence of prior TB infection should be given prophylaxis in accordance with Centers for Disease Control and Prevention (CDC) guidelines.

Who cannot join

Subjects who have had prior treatment with cyclophosphamide, chlorambucil or any other Tumor Necrosis Factor (TNF) biologic as etanercept, infliximab, anakinra, abatacept and adalimumab.
Subjects who have been previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia (CD4 lymphocytes <= 500/mm3).
Subject has had prior treatment with intravenous (IV) immunoglobulin or any investigational agent within 30 days of screening visit.
Subject has a history of cancer within the past 10 years other than resected basal cell or squamous cell carcinomas of the skin.
Subject has a history of malignant lymphoma or leukemia regardless of time since diagnosis.
Subject has a history of or current acute inflammatory joint disease of origin other than RA, e.g., Mixed Connective Tissue Disease (MCTD), Systematic Lupus Erythematosus (SLE), etc.

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Subject has a history of uncontrolled diabetes mellitis, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent cerebrovascular accident (CVA) (within 3 months) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
Subject has a history of active tuberculosis or listeriosis, or other active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoan or fungal infections.
Subject has a positive serology for Hepatitis B or Hepatitis C indicating active infection.
Subject has a history of positive HIV status defined by an enzyme-linked immunosorbent assay (ELISA) positive test confirmed by a Western blot test and/or polymerase chain reaction (PCR).
Subject has had a persistent or severe infection(s) requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days, or oral antibiotics within 14 days, prior to enrollment.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Puerto Rico10 sites

Study site
Aguada, 00602
Study site
Bayamón, 00961
AJP Med, Inc. PSA
Caguas, 00726
Study site
Caguas, 00726
Study site
Humacao, 00777
Study site
Manati, 00674
Study site
Rio Piedras, 00923
Study site
Rio Piedras, 00927
San Juan Arthritis & Research Center
San Juan, 00910
Study site
San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)

Conditions: Rheumatoid Arthritis
Being tested: Humira (adalimumab)
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

Humira (adalimumab)Drug
Also called ABT-D2E7, adalimumab, Humira
40 mg eow

Study groups in NCT00761514
Study group	Role	What they receive
1	Experimental	All subjects will receive Adalimumab Receives: Drug: Humira (adalimumab)

What is being measured

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

Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.
Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.
Measured: Week 24 of treatment

Secondary outcomes (1)

Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score
On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.
Measured: Week 24 of treatment

Timeline

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

Nov 2006Aug 2008

First posted29 Sep 2008 (estimated)
Study startNov 2006
Primary completionAug 2008
Study completionAug 2008

Why it stopped: The study was terminated due to low enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761514
Sponsor's protocol ID: W06-407
Acronym: VIVIR
Status last verified: Oct 2009
First submitted: 25 Sep 2008
Last updated: 19 Nov 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)
ClinicalTrials.gov ID: NCT00761514
Acronym / sponsor ID: VIVIR / W06-407
Conditions: Rheumatoid Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to low enrollment.
Enrolment: 14 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 19 Nov 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Humira (adalimumab)All subjects will receive Adalimumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.
Subject is 18 years of age or older.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
If female, the results of a serum pregnancy test performed at Screening, prior to the first dose of Humira (adalimumab) must be negative.
Subject has confirmed diagnosis of active rheumatoid arthritis as defined by >= 6 swollen joints and >= 9 tender joints.

Key exclusion criteria (11 listed)

Subjects who have had prior treatment with cyclophosphamide, chlorambucil or any other Tumor Necrosis Factor (TNF) biologic as etanercept, infliximab, anakinra, abatacept and adalimumab.
Subjects who have been previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia (CD4 lymphocytes <= 500/mm3).
Subject has had prior treatment with intravenous (IV) immunoglobulin or any investigational agent within 30 days of screening visit.
Subject has a history of cancer within the past 10 years other than resected basal cell or squamous cell carcinomas of the skin.
Subject has a history of malignant lymphoma or leukemia regardless of time since diagnosis.

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
Humira (adalimumab)Also: ABT-D2E7, adalimumab, Humira40 mg eow	Drug	1

Primary outcome

Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.
Time frame: Week 24 of treatment
Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.

1 secondary outcome

Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score
Time frame: Week 24 of treatment

Results and safety

Results posted to the registry on 19 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-label Treatment With 40 mg Adalimumab Every Other Week	14	7

Primary outcome: Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.

Time frame: Week 24 of treatment. Number. Unit: Percent change in average total score

Measure	Open-label Treatment With Adalimumab 40 mg Every Other Week n = 14
Value	59

Population analysed: Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open-label Treatment With 40 mg Adalimumab Every Other Week	2 of 14 (14.3%)	9 of 14 (64.3%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early due to lack of enrollment. Only 7 subjects completed 24 weeks of treatment. That number is too small to provide reliable data on the effectiveness of the treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Link to product informationLink provided by the sponsor.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Carlos R. Rivera-Vàzquez, MD study director

Abbott

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Humira (adalimumab) in people with Rheumatoid Arthritis, run by Abbott at 10 sites in Puerto Rico.

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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities. (time frame: Week 24 of treatment). 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 NCT00761514.

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 19 Nov 2009.