Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Necrosis

Arthritis

Arthritis, Rheumatoid

Joint Diseases

Rheumatic Diseases

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Connective Tissue Diseases

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Antineoplastic Agents

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All Drugs and Chemicals

Anti-Inflammatory Agents

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Methotrexate

Tumor Necrosis Factor Inhibitors

Etanercept

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Certolizumab Pegol

Golimumab

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Folinic Acid

Folate

Vitamin B9

Andecaliximab 300 mg for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Andecaliximab 150 mg + placebo for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Placebo weekly for 12 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

On the Week 12 visit, eligible participants may choose to participate in the open-label portion of the study to receive open-label andecaliximab 300 mg for 52 weeks, in addition to their current regimen of a TNF inhibitor and methotrexate.

Administered via subcutaneous injection once weekly

Andecaliximab

Placebo

Administered orally weekly as part of the participant's current treatment regimen

An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.

TNF Inhibitor

Gilead Study Director

The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

The plasma concentrations of andecaliximab were not collected and were not analyzed.

Gilead Sciences

Safety Analysis Set: participants who received at least 1 dose of study drug

Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg (Double-Blind)

Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 150 mg (Double-Blind)

Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Placebo (Double-Blind)

Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg (Open-Label)

Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 300 mg

Double-Blind Period: Andecaliximab 150 mg administered via subcutaneous injection + placebo once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Andecaliximab 150 mg

Double-Blind Period: Placebo administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity.

Disease Activity Score C-reactive Protein (DAS28(CRP))

Gilead decided to discontinue the development of andecaliximab in RA and this study was terminated. The decision was not due to any safety concerns. Because only 15 participants were enrolled, no formal statistical testing was completed.

Gilead Clinical Study Information Center

Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.

Change From Baseline in DAS28(CRP) at Week 12

Full Analysis Set: all randomized participants who received at least 1 dose of study drug

Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12

Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12

Plasma Concentration of Andecaliximab

Double-Blind Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for 12 weeks, in addition to participant's current regimen of a tumor necrosis factor (TNF) inhibitor and methotrexate

Open-Label Period: Andecaliximab 300 mg administered via subcutaneous injection once weekly for up to 52 weeks, in addition to participant's current regimen of a TNF inhibitor and methotrexate

Double-Blind Treatment Period

Open-Label Treatment Period

Infections

Wounds and Injuries

Nervous System Diseases

Spondylitis

Spondylarthritis

Enthesopathy

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Tendinopathy

Muscular Diseases

Tendon Injuries

Adrenergic alpha-Antagonists

Spondyloarthritis patients who was initiated TNF alfa blocker

TNF inhibitors are widely used in patients with spondyloarthritis

Biological therapies should be considered in patients with high disease activity despite nonsteroid antiinflammatory drug treatment. The first option among biological therapies is anti-Tumor Necrosis Factor (anti-TNF) drugs. In recent years, anti-TNF treatments have shown that clinical and ultrasonographic enthesitis may improve as well as disease activity, quality of life and acute phase reactants. In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.In this prospective study, we aimed to evaluate the clinical and ultrasonographic evaluation of enthesitis and to determine its response to anti-TNF treatment in patients with SpA.

All patients were evaluated by the researcher who had a 10-year experience of musculoskeletal ultrasonography and is blind to clinical evaluation.

Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis

Clinical and Ultrasonographic Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Patients With Spondyloarthritis

Madrid Sonographic Enthesitis Index was used to screen etheseal sites

Bath Ankylosing Spondylitis Disease Activity Index was used

Ankylosing Spondylitis Disease Activity Score was used

Ankylosing Spondylitis Quality of Life was used

Bath Ankylosing Spondylitis Functionality Index was used

Gunay ER

Medical Doctor

Herbal and Botanical

Tripterygium

Treated with oral methotrexate and two placebos.

Treated with oral Tripterygium Wilfordii and two placebos.

Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.

Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.

Tripterygium Wilfordii

Oral methotrexate 7.5-15mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 15mg (max 0.3mg/Kg) per week in 4 weeks. Folic acid at the dose of 5 mg per week were applied to all participants.

Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.

Yisaipu

Xuan Zhang, MD

In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis.

This study evaluates the efficacy and safety of YISAIPU plus Tripterygium wilfordii (T2w) for the treatment of RA patients. YISAIPU is a recombinant human tumor necrosis factor receptor fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of Tripterygium wilfordii Hook F.

Objectives:

1. To compare the efficacy of YISAIPU plus T2w versus MTX monotherapy for the treatment of signs and symptoms of RA.
2. To evaluate the safety of YISAIPU plus T2w in patients with RA for 24 weeks.

Design:

This is a randomized, 24-week, double-blind, parallel group study, and 506 patients with active RA will be randomized in a 1:1:1:1 ratio to one of the following four parallel treatment arms:

1. Methotrexate monotherapy
2. T2w monotherapy
3. YISAIPU plus methotrexate
4. YISAIPU plus T2w

Escape:

On week 13, all participants with inadequate response, defined as a \<30% improvement of swollen and tender joint counts from baseline, will switch to YISAIPU plus T2w treatment throughout the study.

Endpoints :

1. ACR20, ACR50 and ACR70 response rates at 12 and 24 weeks.
2. DAS 28 (CRP) and DAS 28 (ESR) at 12 and 24 weeks.
3. EULAR response rates at 12 and 24 weeks.
4. Health assessment questionnaire (HAQ) at 12 and 24 weeks.
5. Patient assessment of arthritis pain at 12 and 24 weeks.
6. Patient and physician global assessment of arthritis at 12 and 24 weeks.

Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA

Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis

Incidence of adverse events and sever adverse events (SAE), including hospitalized or Treatment-emergent adverse events, during 24-week study.

The difference of ACR50 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

The difference of ACR20 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

The difference of ACR20, ACR50 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 24.

The change in DAS28 score from baseline to week 24 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX).

DAS28 ＝ 0.56\*SQRT(TJC28) + 0.28\*SQRT(SJC28) + 0.36\*ln(CRP + 1) + 0.014\*GH + 0.96

* TJC28: The number of tender joints (0-28).
* SJC28: The number of swollen joints (0-28).
* CRP: The C-Reactive Protein level (in mg/l).
* GH: The patient global health assessment (from 0=best to 100=worst).

The 28 joint: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.

The difference of proportions of patients meeting EULAR response between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.

The change in HAQ-DI score from baseline to week 12 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX).

HAQ-DI is an index measuring the quality of life related to health, which includes 20 questions in terms of three categories:

* from 0 to 1: mild difficulties to moderate disability,
* from 1 to 2: disability moderate to severe,
* from 2 to 3: severe to very severe disability.

The mean score is recorded as the result.

Peking Union Medical College Hospital

Professor

Tofacitinib

Infliximab

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Janus Kinase Inhibitors

Protein Kinase Inhibitors

Real-World Evidence (RWE) and RCT-Duplicate

First eligible prescription for treating rheumatoid arthritis (RA)

Seoyoung C Kim, MD, ScD, MSCE

There are two main aims of this study.

First aim is to compare the risk of composite cancer outcomes, between patients treated with tofacitinib and patients treated with TNF inhibitors (TNFi) for rheumatoid arthritis (RA) among, 1) "real world evidence (RWE)" cohorts including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohorts including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.

Second aim is to examine the risk of common solid cancers (lung, colorectal, breast, prostate), hematological cancers, and non-melanoma skin cancer as separated endpoints when comparing tofacitinib with TNFi in patients with RA among, 1) "real world evidence (RWE)" cohort including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohort including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis	NCT02862574	Rheumatoid Arth...	Andecaliximab Placebo Methotrexate TNF Inhibitor	18 Years - 80 Years	Gilead Sciences
Enthesitis Assessment Before and After Anti-Tumor Necrosis Factor Treatment in Spondyloarthritis	NCT04953871	Spondyloarthrit... Enthesitis Anti-Tumor Necr...	TNF Inhibitor	18 Years - 65 Years	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA	NCT03589833	Arthritis, Rheu...	Tripterygium Wi... Methotrexate Yisaipu	18 Years - 65 Years	Peking Union Medical College Hospital
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints	NCT04798287	Rheumatoid Arth...	Tofacitinib TNF Inhibitor	18 Years -	Brigham and Women's Hospital

Spots Global Cancer Trial Database for tnf inhibitor