A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 5 sites in Russia.

Completed

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

Trial summary

A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs)… 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?: adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 5 sitesRussia
Study dates: Dec 2007to Feb 2010
Phase: Phase 3
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

Males and females >= 18 years of age.
A negative pregnancy test (human chorionic gonadotropin in serum samples) for women of childbearing potential prior to start of study treatment.
Female subject is either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) 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 throughout the study and for 150 days after study completion:
Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
Contraceptives (oral, parenteral, patch) for three months prior to study drug administration.
A vasectomized partner.

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American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for at least 6 months.
Subjects must meet the following three criteria:
Disease Activity Score (28 joints) more or equal 3.2 (at Baseline only)
At least 6 swollen joints out of the 66 assessed
At least 8 tender joints out of the 68 assessed
Subjects must have a C-reactive protein >= 1.5mg/dL or erythrocyte sedimentation rate >= 28 mm/1h.
Unsatisfactory response or intolerance to prior disease modifying anti-rheumatic drugs (must have failed at least 1 disease modifying anti-rheumatic drug).
Able and willing to administer subcutaneous injections.
Able and willing to give written informed consent and to comply with the requirements of the study protocol.
Documented negative purified protein derivative test, defined as < 5 mm induration, or willingness and ability to start tuberculosis prophylaxis before first dose of study drug if the purified protein derivative result is positive and the chest X-ray is not suggestive of active tuberculosis and there is no history of active tuberculosis.

Who cannot join

Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil within at least 5 years before enrollment.
Prior treatment with intravenous immunoglobulin or any investigational agent "chemical" in nature within 30 days, or 5 half lives of the product, whichever is longer.
Prior treatment with cyclosporine within the last 6 months.
Prior treatment with investigational biologic therapy.
Subject has chronic arthritis diagnosis before the age 17 years.
Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study).

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History of an allergic reaction or significant sensitivity to the constituents of study drug (adalimumab).
Treatment within the last 2 months with approved biologic therapy (e.g. infliximab) prior to Baseline.
Prior treatment with total lymphoid irradiation.
History of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
History of or current acute inflammatory joint disease of origin other than rheumatoid arthritis, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
Subject is known to have immune deficiency, history of positive human immunodeficiency virus status or is immunocompromised.
Persistent chronic infection, or severe infections requiring hospitalization or treatment with intravenous antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
Female subjects who are pregnant or breast-feeding or is considering becoming pregnant during the study or for 150 days after the last dose of study medication.
History of clinically significant drug or alcohol abuse in the last year.
Previous diagnosis or signs of central nervous system demyelinating diseases.
History of untreated or active tuberculosis, histoplasmosis or listeriosis.
History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. fibrosis, cirrhosis, hepatitis).
Screening clinical laboratory analysis showing any of the following abnormal laboratory results:
Aspartate transaminase or alanine transaminase > 1.75 x the upper limit of normal.
Serum total bilirubin >= 1.5 mg/dL (>= 26 micromol/L).
Creatinine > 1.5 mg/dL (133 micromol/L) in subjects < 65 years old and > upper limit of normal range in subjects >= 65 years old.
Positive Hepatitis B or C serology indicative of previous or current infections.
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

Site Ref # / Investigator 17682
Kazan', 420095
Site Ref # / Investigator 7417
Moscow, 115522
Site Ref # / Investigator 17681
Moscow, 117513
Site Ref # / Investigator 7401
Moscow, 119049
Site Ref # / Investigator 18081
Saint Petersburg, 191015

Other trials in Russia

About this study

Official title: An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Read the detailed description

This is an open-label, multicenter study designed to establish the safety and efficacy of adalimumab in the treatment of moderate to severely active rheumatoid arthritis. A total of 100 subjects with inadequate preexisting standard anti-rheumatic therapy were enrolled at 5 sites in Russia.

Conditions: Rheumatoid Arthritis
Being tested: adalimumab
Keywords: Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

adalimumabDrug
Also called ABT-D2E7, Humira
Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Study groups in NCT01231321
Study group	Role	What they receive
adalimumab	Experimental	Adalimumab / pre-filled syringe 40 mg/0.8 ml Receives: Drug: adalimumab

What is being measured

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

Frequency of Adverse Events
Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported.
Note:
Severe events considerably interfered in patients' usual activities and may have been life-threatening.
Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.
Measured: Up to 34 weeks (24 week study treatment plus 70-day follow-up period)
Changes of Physical Examination
Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.
Measured: Baseline and 24 weeks
Deviation From Normal Laboratory Ranges
Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory.
Note abbreviations used in table:
Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate
Measured: 24 weeks
Vital Sign Values
Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory.
Note, in table, BP = blood pressure.
Measured: 24 weeks

Secondary outcomes (1)

Change in Disease Activity Score (DAS28) Compared With Baseline
The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).
Measured: Baseline and 24 weeks

Timeline

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

Dec 2007Feb 2010

First posted1 Nov 2010 (estimated)
Study startDec 2007
Primary completionFeb 2010
Study completionFeb 2010

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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01231321
Sponsor's protocol ID: W06-406
Status last verified: Apr 2011
First submitted: 28 Oct 2010
Last updated: 26 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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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 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01231321
Acronym / sponsor ID: W06-406
Conditions: Rheumatoid Arthritis
Keywords: Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 1 Nov 2010 (estimated)
Results: Posted 24 Mar 2011

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
adalimumab	Experimental	Drug: adalimumabAdalimumab / pre-filled syringe 40 mg/0.8 ml

Who may qualify

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

Key inclusion criteria (16 listed)

Males and females >= 18 years of age.
A negative pregnancy test (human chorionic gonadotropin in serum samples) for women of childbearing potential prior to start of study treatment.
Female subject is either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) 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 throughout the study and for 150 days after study completion:
American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for at least 6 months.
Subjects must meet the following three criteria:

Key exclusion criteria (25 listed)

Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil within at least 5 years before enrollment.
Prior treatment with intravenous immunoglobulin or any investigational agent "chemical" in nature within 30 days, or 5 half lives of the product, whichever is longer.
Prior treatment with cyclosporine within the last 6 months.
Prior treatment with investigational biologic therapy.
Subject has chronic arthritis diagnosis before the age 17 years.

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
adalimumabAlso: ABT-D2E7, HumiraAdalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.	Drug	adalimumab

Primary outcome

Frequency of Adverse Events
Time frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period)
Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.
Changes of Physical Examination
Time frame: Baseline and 24 weeks
Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.
Deviation From Normal Laboratory Ranges
Time frame: 24 weeks
Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate
Vital Sign Values
Time frame: 24 weeks
Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure.

1 secondary outcome

Change in Disease Activity Score (DAS28) Compared With Baseline
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 24 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	100	95

Primary outcome: Frequency of Adverse Events

Time frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period). Number. Unit: participants

Measure	Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL n = 100
Adverse events	38
Serious adverse events	1
Severe adverse events	1
Possibly or probably related to adalimumab	24
Adverse events leading to discontinuation	3
Fatal adverse events	0

Population analysed: All enrolled subjects were included in this intent-to-treat (ITT) analysis.

Primary outcome: Changes of Physical Examination

Time frame: Baseline and 24 weeks. Number. Unit: participants

Measure	Change From Normal to Abnormal n = 99	Change From Abnormal to Normal n = 99
General Appearance	0	0
Head	0	0
Ears	0	0
Eyes	1	0
Nose	0	0
Throat	0	0
Neck	0	0
Thyroid	0	0

Population analysed: All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.

Primary outcome: Deviation From Normal Laboratory Ranges

Time frame: 24 weeks. Number. Unit: participants

Measure	Below Reference Range n = 100	Above Reference Range n = 100
Basophils (%) (ref. range: 0% - 1%) (n = 95)	0	0
Basophils (ref. range 0 - 2 x 10^9/L) (n = 94)	0	0
Eosinophils (%) (ref. range 1% - 5%) (n = 95)	17	11
Eosinophils (ref. range 0 - 1 x 10^9/L) (n = 94)	0	0
Erythrocytes (ref. range 4 - 5 x 10^12/L) (n = 95)	15	9
ESR (ref. range 0 - 30 mm/h) (n = 75)	0	14
Hematocrit (ref. range 35% - 47%) (n = 95)	15	2
Hemoglobin (ref. range 12 - 16 g/dL) (n = 95)	33	1

Population analysed: All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.

Primary outcome: Vital Sign Values

Time frame: 24 weeks. Number. Unit: participants

Measure	Below Reference Range n = 99	Above Reference Range n = 99
Systolic BP (ref. range 100 - 140 mm Hg)	1	2
Diastolic BP (ref. range 60 - 100 mm Hg)	0	0
Pulse (ref. range 50 - 90 beats/min)	0	0
Body temperature (ref. range 36 - 37 degrees C)	1	0

Population analysed: All subjects with available data were included in this intent-to-treat (ITT) analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent up to 70 days after the last injection of adalimumab.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL	1 of 100 (1%)	38 of 100 (38%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
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.

Konstantin Gudkov, MD study director

Abbott

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Rheumatoid Arthritis, run by Abbott at 5 sites in Russia.

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 16 inclusion and 25 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 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Mar 2011). 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?

Frequency of Adverse Events (time frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period)). The study lists 4 primary outcomes in all. 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 NCT01231321.

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 26 Apr 2011.